Subjective versus objective dental side effects from oral sleep apnea appliances.

PURPOSE: Occlusal changes are common during long-term treatment with oral appliances (OAs) for sleep apnea. The aim of the present study was to compare subjectively reported bite changes with objective findings. METHODS: Consecutive adherent treated patients were asked to participate in this study. The patients responded to two questionnaires using numeric visual analogue scales (VAS), ranging from 0 (not at all) to 10 (very much). The first questionnaire included open questions and the second questionnaire comprised specific questions about side effects. Measurements of overjet, overbite, and space for the teeth were made on plaster casts taken before treatment start and at follow-up. RESULTS: Thirty-eight (12 women) patients with a median age of 64 years (interquartile range (IQR) 57 to 69 years) and a median treatment time of 9.5 years (IQR 5.8 to 14.3 years) were included. Overjet, overbite, the molar relationship, and the irregularity of the lower front teeth had changed significantly during treatment. There were no associations between any of the patients' responses and the objectively measured bite changes. Younger patients, those with a small baseline overjet or overbite and those who developed an anterior crossbite were more likely to report bite changes. CONCLUSIONS: Patients who choose to continue long-term treatment with oral appliances for sleep apnea are unaware of various types of bite changes. Such changes will, however, progressively increase in magnitude and be more difficult to take care of, if needed. It is therefore important continuously to follow up patients in regard to bite changes.

Changes in lower incisor irregularity during treatment with oral sleep apnea appliances.

PURPOSE: The purpose of this study is to test the hypothesis that a flexible oral appliance without incisor coverage (OAFlex) increases the irregularity of the front teeth compared with a rigid appliance with incisor coverage (OARigid) in patients treated for obstructive sleep apnea (OSA). METHOD AND PATIENTS: Nineteen patients (10 men) who had used OARigid and 22 patients (19 men) who had used OAFlex with a median age of 61 years (IQR of 56 to 67 years) who had been treated during a median period of 2.9 years (IQR of 2.7 to 3.1 years) were included in the study. There was no difference in age (p = 0.601) or treatment time (p = 0.432) between the two appliance groups. The patients had clinical examinations, responded to a questionnaire, and had impressions taken for plaster casts. The irregularity of the front teeth was measured by Little's Index, where the combined linear displacement of all the front teeth is assessed. Changes between baseline and follow-up were compared between the two groups. RESULTS: The OAFlex group increased the irregularity of their lower front teeth by 0.3 mm (p = 0.018), while the OARigid group had unchanged frontal irregularity (p = 0.717). The difference between the groups was significant (p = 0.035). There were no changes in the irregularity of the upper front teeth in either group. Patient satisfaction with treatment did not differ between the two appliances. CONCLUSIONS: The present results support the hypothesis that a flexible OA without incisor coverage increases the irregularity of the lower front teeth compared with a rigid OA with incisor coverage.

Long-term efficacy of an oral appliance in early treated patients with obstructive sleep apnea.

PURPOSE: The purpose of the present study was to evaluate the long-term efficacy of oral appliances (OAs) in early treated patients with obstructive sleep apnea (OSA). METHOD AND PATIENTS: Polysomnographic sleep recordings without and with an OA were performed at treatment start and in patients who had been continuously treated with OAs for at least 15 years. RESULTS: Nine patients (eight men) with a median age of 68.1 years (interquartile range (IQR) 60.0 to 76.3 years) and a median treatment time of 16.5 years (IQR 16.3 to 18.0 years) were included. The apnea-hypopnea index decreased from a median of 17.3 (IQR 9.7 to 26.5) to 7.2 (IQR 4.0 to 9.6; p = 0.03) at the short-term follow-up. After long-term use, the apnea-hypopnea index was 32.4 (IQR 22.2 to 58.8) without the device and 35.1 (IQR 13.6 to 46.2) with it (p = 0.08). There were increases in the apnea-hypopnea index, both without the device (p = 0.02) and with it (p = 0.008). The degree of mandibular advancement did not differ between the two study occasions (p = 1.0). CONCLUSIONS: Patients treated with oral appliances may experience deteriorations in disease severity and treatment efficacy during continuous long-term OA treatment. Regular follow-up schedules with renewed sleep apnea recordings should be considered for these patients in order to avoid suboptimal or a total loss of effects on sleep apneas.

An oral appliance with or without elastic bands to control mouth opening during sleep-a randomized pilot study.

BACKGROUND: Oral appliances (OAs) hold the lower jaw forward to reduce obstructive sleep apneas. Some OA designs allow mouth opening, which influences the forward positioning of the lower jaw. The aim of this pilot study was to compare the efficacy of an adjustable, custom-made OA (Narval®) in its original design, which allowed mouth opening, with the same OA with elastic bands that restricted mouth opening. METHODS: Consecutive patients with an apnea-hypopnea index (AHI) of ≥15 were randomized to start with an OA either with or without elastic bands in a single-blinded, crossover, pilot study. The patients underwent acclimatization and titration. After 3 weeks use of each device, they had renewed sleep apnea recordings and responded to questionnaires. Washout periods took place between the tests. RESULTS: Ten subjects with a median AHI of 19.7 (interquartile range (IQR) 17.3 to 31.8) were included. The AHI decreased to 3.1 (IQR 1.5-14.7) (p < 0.01) with the OA and to 5.1 (IQR 2.4-14.3) (p < 0.01) with the OA with elastic bands, with no difference between them (p = 0.7). The two subjects with severe obstructive sleep apnea (OSA) almost halved their supine AHI with, as compared to without, elastic bands. The majority of the patients preferred to use the elastic bands. CONCLUSIONS: This pilot study indicates that elastic bands markedly reduced the supine AHI in two subjects with severe sleep apnea as compared to without elastic bands. The majority of the patients preferred the use of elastic bands, although no significant difference in the AHI was observed with versus without the elastic bands in the whole sample.

Treatment of elderly patients with snoring and obstructive sleep apnea using a mandibular advancement device.

INTRODUCTION: The simplicity of oral appliance therapy in the treatment of adult patients with snoring and obstructive sleep apnea (OSA) has resulted in a worldwide interest for this treatment modality. Mandibular advancement devices (MADs) that hold the lower jaw forward during sleep are mainly indicated for patients with milder OSA and those with CPAP intolerance. There has been minor attention on age when suggesting treatment alternatives for patients with OSA. Some studies indicate that there is a weak negative relationship between treatment success from MADs and higher age, but no studies have stratified their samples with respect to age. OBJECTIVE: The present aim was to compare the effects and side effects from MADs between an elderly group of patients (>65 years of age) and a younger age group that were extracted from two of our previous studies. RESULTS: The results showed no difference between the elderly and the younger patients in success rate or the degree of bite changes from MAD treatment. CONCLUSION: These findings indicate that MADs represent an alternative to CPAP irrespective of the age of the patient.

Mandibular tori size is related to obstructive sleep apnea and treatment success with an oral appliance.

PURPOSE: Obstructive sleep apnea (OSA) is a common disorder characterized by repetitive upper airway obstruction during sleep. We aimed to investigate whether mandibular tori, exostoses that appear on the lingual surface of the lower jaw, are related to OSA and the effect of an oral appliance (OA) in OSA patients. METHODS: Six hundred snoring patients with a mean age of 52 years (range 23-75 years) and a mean respiratory disturbance index (RDI) of 15 (range 0-76), who were consecutively referred for OA treatment, were included. The size of the tori was measured on plaster casts with a digital sliding caliper. RESULTS: Twenty-seven percent of the patients had mandibular tori, with a similar prevalence in snorers and patients with mild, moderate and severe OSA. Tori size differed between severity groups. Thick tori (≥2.9 mm) were associated with an RDI of <30, odds ratio (OR) 4.7 (p = 0.01), adjusted for age, gender and body mass index (BMI; kg/m(2)). Complete treatment response with OA was related to thick tori, OR = 2.5 (p = 0.02), adjusted for disease severity, age, gender, BMI (kg/m(2)), weight changes (kg) and mandibular repositioning. CONCLUSIONS: Patients with milder disease are more likely to have larger tori than patients with severe OSA. Treatment success with an OA occurs more frequently in patients with larger tori than in patients with no tori or small tori.

Starting Mandibular Advancement Device Therapy in Patients with Good Protrusive Capacity: A Randomized Pilot Study.

Objective: Discomfort has been related to the poor acceptance of a mandibular advancement device (MAD) in patients with obstructive sleep apnea. The present study compared severe initial side effects between a smaller and a larger degree of mandibular advancement in patients with a good protrusive capacity. Methods: Consecutive patients with obstructive sleep apnea and a good protrusive capacity (≥8 mm) were randomized to start treatment with the mandible advanced by either 70% of maximum protrusion (Adv70%) or by 4 mm (Adv4mm) in a pilot study with a parallel design. The main outcome was tenderness or pain in the teeth or jaws using a 0-10 visual analogue scale (VAS) (from "not at all" to "very extensive") or excluded use because of side effects during the first week of treatment. Secondary outcomes included salivation problems and bite changes. Results: Eighteen patients were randomly selected and 17 patients fulfilled the study protocol. Four patients in the Adv70% group and none in the Adv4mm group reported severe tenderness or pain (VAS ≥7) on five or more of the seven days (p=0.03). The degree of mandibular advancement measured in millimeters correlated with the number of days with severe side effects, r=0.64 (p=0.006). The secondary side effects were minor. Conclusion: Starting MAD treatment with 70% mandibular advancement was related to more severe side effects during the first week of treatment compared with a smaller fixed millimeter value in patients with a good protrusive capacity in this pilot study.

The role of oral appliance therapy in obstructive sleep apnoea.

There is now widespread recognition within the world of sleep medicine of the increasing importance of dental sleep medicine and, in particular, the role of oral appliance therapy (OAT) in the management of adults with obstructive sleep apnoea (OSA). For the purpose of this review, the term OAT refers to a custom-made intra-oral appliance, which acts to posture the mandible in a forward and downward direction, away from its natural resting position. Whilst nasally applied continuous positive airway pressure remains the "gold standard" in nonsurgical OSA management, OAT remains the recognised alternative treatment.This review of OAT aims to provide an evidence-based update on our current understanding of their mode of action, exploring the potential anatomical and physiological impact of their use in preventing collapse of the upper airway; the current clinical practice guidelines, including the recently published National Institute of Clinical Excellence 2021 guidance, in conjunction with the American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine; optimal design features, comparing the role of custom-made versus noncustom OAT devices and the importance of titration in achieving a dose-dependent effect; patient predictors, preference and adherence to OAT; its impact on a range of both patient- and clinician-centred health outcomes, with a comparison with CPAP; the limitations and side-effects of providing OAT; and, finally, a look at future considerations to help optimise the delivery and outcomes of OAT.

Non-CPAP therapies in obstructive sleep apnoea: mandibular advancement device therapy.

Mandibular advancement devices (MADs) represent the main non-continuous positive airway pressure (non-CPAP) therapy for patients with obstructive sleep apnoea (OSA). The aim of the European Respiratory Society Task Force was to review the evidence in favour of MAD therapy. Effects of tongue-retaining devices are not included in this report. Custom-made MADs reduce apnoea/hypopnoea index (AHI) and daytime sleepiness compared with placebo devices. CPAP more effectively diminishes AHI, while increasing data suggest fairly similar outcomes in relation to symptoms and cardiovascular health from these treatments. Patients often prefer MADs to CPAP. Milder cases and patients with a proven increase in upper airway size as a result of mandibular advancement are most likely to experience treatment success with MADs. A custom-made device titrated from an initial 50% of maximum mandibular advancement has been recommended. More research is needed to define the patients who will benefit from MAD treatment compared with CPAP, in terms of the effects on sleep-disordered breathing and on other diseases related to OSA. In conclusion, MADs are recommended for patients with mild to moderate OSA (Recommendation Level A) and for those who do not tolerate CPAP. The treatment must be followed up and the device adjusted or exchanged in relation to the outcome.

Endorsement of: "treatment of adult obstructive sleep apnea with positive airway pressure: an American academy of Sleep Medicine Clinical Practice Guideline" by World Sleep Society.

Guidelines for the evaluation and management of sleep disorders from national societies provide recommendations that may be regionally appropriate but may not always be practical or relevant in other parts of the world. A task force of experts from the World Sleep Society's (WSS) International Sleep Medicine Guidelines Committee and Sleep and Breathing Disorders Taskforce reviewed the American Academy of Sleep Medicine's Clinical Practice Guideline on the Treatment of Adult Obstructive Sleep Apnea (OSA) with Positive Airway Pressure with respect to its relevance and applicability to the practice of sleep medicine by sleep specialists in various regions of the world. To improve the evaluation of the guideline, surveys were sent by the senior author and the WSS to approximately 800 sleep doctors around the world to query the availability of OSA treatments in their respective region. The task force and the WSS guidelines committee endorsed the AASM's CPAP guidelines with respect to the indications for PAP therapy, utilization of different PAP modalities, and concurrent strategies to improve outcomes, noting appropriate caveats for universal applicability.

Current and novel treatment options for obstructive sleep apnoea.

Obstructive sleep apnoea is a challenging medical problem due to its prevalence, its impact on quality of life and performance in school and professionally, the implications for risk of accidents, and comorbidities and mortality. Current research has carved out a broad spectrum of clinical phenotypes and defined major pathophysiological components. These findings point to the concept of personalised therapy, oriented on both the distinct clinical presentation and the most relevant pathophysiology in the individual patient. This leads to questions of whether sufficient therapeutic options other than positive airway pressure (PAP) alone are available, for which patients they may be useful, if there are specific indications for single or combined treatment, and whether there is solid scientific evidence for recommendations. This review describes our knowledge on PAP and non-PAP therapies to address upper airway collapsibility, muscle responsiveness, arousability and respiratory drive. The spectrum is broad and heterogeneous, including technical and pharmaceutical options already in clinical use or at an advanced experimental stage. Although there is an obvious need for more research on single or combined therapies, the available data demonstrate the variety of effective options, which should replace the unidirectional focus on PAP therapy.

European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea.

Treatment of obstructive sleep apnoea (OSA) in adults is evolving, as new therapies have been explored and introduced in clinical practice, while other approaches have been refined or reconsidered. In this European Respiratory Society (ERS) guideline on non-continuous positive airway pressure (CPAP) therapies for OSA, we present recommendations determined by a systematic review of the literature. It is an update of the 2011 ERS statement on non-CPAP therapies, advanced into a clinical guideline. A multidisciplinary group of experts, including pulmonary, surgical, dentistry and ear-nose-throat specialists, methodologists and patient representatives considered the most relevant clinical questions (for both clinicians and patients) relating to the management of OSA. Eight key clinical questions were generated and a systematic review was conducted to identify published randomised clinical trials that answered these questions. We used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess the quality of the evidence and the strength of recommendations. The resulting guideline addresses gastric bypass surgery, custom-made dual-block mandibular advancement devices, hypoglossal nerve stimulation, myofunctional therapy, maxillo-mandibular osteotomy, carbonic anhydrase inhibitors and positional therapy. These recommendations can be used to benchmark quality of care for people with OSA across Europe and to improve outcomes.

Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea.

RATIONALE: The efficacy of immediate adaptation of mandibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing (SDB) has been demonstrated in clinical studies. To date, there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices. OBJECTIVES: Our purpose was to compare the efficacy of both types of devices in patients with SDB. METHODS: A randomized controlled cross-over trial, comprising 4 months of treatment with a thermoplastic and a custom-made device, with a 1-month washout interval. MEASUREMENTS AND MAIN RESULTS: A total of 35 patients (29 males; age, 49 +/- 9 yr; apnea-hypopnea index [AHI], 13 +/- 11 events/h; body mass index, 28 +/- 4 kg/m(2)) completed the protocol. AHI was only reduced with the custom-made device (P = 0.005). In addition, this device reduced snoring to a greater extent than the thermoplastic device. The success rate was higher with the custom-made device (60 vs. 31%; P = 0.02). One-third of the patients demonstrated compliance failure with the thermoplastic device, mainly because of insufficient overnight retention. Total failure rate with the thermoplastic device was 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference (P < 0.0001). CONCLUSIONS: In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.

Update on oral appliance therapy.

Oral appliances are increasingly recommended for selected patients with obstructive sleep apnoea (OSA) and those who do not tolerate nor prefer continuous positive airway pressure. The most commonly used oral appliance advances the lower jaw during sleep, the so-called mandibular advancement device (MAD). Patients seek treatment because of disturbing snoring, daytime symptoms, apnoeas that disturb sleep and the longer term consequences with regard to cardiovascular risks. MADs reduce the apnoea-hypopnoea index, although to various degrees among patients. Effects on daytime sleepiness have been observed mainly among the more severe OSA patients. Blood pressure may be reduced in MAD-treated OSA patients. There is, however, uncertainty about which patients will respond to this therapy in terms of apnoea reductions, decreased sleepiness and other symptoms, and reduced risk for future impaired health. The occurrence of side-effects also remains difficult to predict at present. The majority of sleep apnoea patients suffer from various comorbidities in terms of cardiovascular diseases, type 2 diabetes and depression. The most recent findings indicate that phenotyping of patients, considering various aspects of this multifaceted disease, will shed more light on the indications for MADs in patients with nightly sleep breathing disturbances. This review summarises the most recent knowledge about MAD treatment.

Nocturnal Blood Pressure Is Reduced by a Mandibular Advancement Device for Sleep Apnea in Women: Findings From Secondary Analyses of a Randomized Trial.

BACKGROUND: Obstructive sleep apnea is associated with high blood pressure. The magnitude of blood pressure effects from sleep apnea treatment is unclear. We aimed to determine the effect of mandibular advancement device therapy on ambulatory nighttime and daytime blood pressure in women and men with daytime sleepiness and snoring or mild to moderate sleep apnea (apnea-hypopnea index, <30). METHODS AND RESULTS: In this 4-month, double-blind, randomized controlled trial comprising 96 untreated patients, 27 women and 58 men, aged 31 to 70 years, completed the study. The active group received individually made adjustable mandibular advancement devices, and the control group was given individually made sham devices, to be used during sleep. Polysomnographic sleep recordings and ambulatory 24-hour blood pressure measurements were performed at baseline and at follow-up. In women with mandibular advancement devices, the mean nighttime systolic blood pressure was 10.8 mm Hg (95% confidence interval, 4.0-17.7 mm Hg; P=0.004) lower than in the women in the sham group, adjusted for baseline blood pressure, age, body mass index, and the apnea-hypopnea index. The mean nighttime adjusted diastolic blood pressure was 6.6 mm Hg (95% confidence interval, 2.7-10.4 mm Hg; P=0.002) lower in the mandibular advancement device group. In men, there were no significant differences in blood pressure at night or during the daytime between the intervention groups. CONCLUSIONS: A mandibular advancement device for obstructive sleep apnea reduces nocturnal blood pressure in women. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00477009.

Physical findings in the upper airways related to obstructive sleep apnea in men and women.

UNLABELLED: CONCLUSIONS, There are gender differences when it comes to the risk factors for sleep apnea. Large tonsils, a high tongue and a wide uvula are risk factors for sleep apnea in men, while large tonsils and a retrognathic mandible are risk factors in women. Upper airway abnormalities including mandibular retrognathia are, however, unable to predict sleep apnea among snorers being investigated for suspected sleep apnea. OBJECTIVES: To identify gender-specific risk factors for obstructive sleep apnea and the diagnostic performance from physical upper airway examinations among snoring men and women investigated because of suspected sleep apnea. PATIENTS AND METHODS: The dimensions of the uvula, tonsils, velopharynx and tongue, and nasal septal deviation, mandibular position, neck circumference, weight, and height were systematically scored in 801 consecutive snoring patients (596 men and 205 women), who had been referred for a primary sleep apnea recording. RESULTS: In men, large tonsils, a high tongue, and a wide uvula were independent factors associated with an apnea-hypopnea index of >15. In women, large tonsils and mandibular retrognathia were independent factors associated with an apnea-hypopnea index of >15. The positive predictive values for upper airway abnormalities ranged between 0.20 and 0.25 in men and between 0.09 and 0.15 in women.

Predictors of long-term orthodontic side effects from mandibular advancement devices in patients with snoring and obstructive sleep apnea.

INTRODUCTION: Orthodontic side effects can complicate the long-term use of mandibular advancement devices (MADs) in the treatment of patients with snoring and obstructive sleep apnea. The aim of this study was to find predictors of dental side effects from monoblock MADs. METHODS: Four hundred fifty patients, who consecutively received treatment with either soft elastomeric or hard acrylic devices, were followed up after 5.4 +/- 0.8 years (mean +/- SD). The continuing patients responded to questionnaires and had dental examinations and plaster casts made. RESULTS: Twenty-seven patients had moved or died during the follow-up period. Two hundred thirty-six of the remaining 423 patients (56%) continued treatment, and 187 of them reported compliance rates of > or = 50% at night. A small reduction in overjet of < 1 mm was associated with a deepbite with an overbite of > 3 mm and an overjet of < or = 3 mm (odds ratio [OR] = 7.5; P = .015), nasal congestion (OR = 2.9; P = .005), or the use of a soft elastomeric device (OR = 2.7; P = .014) controlled for age, sex, treatment time, and mandibular displacement. A small reduction in overbite of < 1 mm was related to a small opening of the mandible of < 11 mm (OR = 2.5; P = .008). CONCLUSIONS: Orthodontic side effects might be predictable on the basis of initial characteristics in dental occlusion and the design of MADs.

The status of cephalometry in the prediction of non-CPAP treatment outcome in obstructive sleep apnea patients.

Obstructive sleep apnea syndrome (OSAS) is the most common sleep disordered breathing disorder (SDB) in adults and is characterized by a recurrent partial or complete collapse of the upper airway during sleep. This can be caused by many factors, sometimes interacting, such as skeletal malformations, soft tissue crowding, respiratory instability and the various effects of aging, obesity and gender that dictate craniofacial and upper airway anatomy. Research has demonstrated that the majority of patients exhibit at least one anatomical component such as retrognathia or a narrow posterior airway space that predisposes to the development of OSAS. Within the predisposing elements for OSAS many seem to point to anatomical characteristics. A standardized and relatively simple radiologic technique to evaluate anatomical craniofacial relationships is cephalometry. This has been used already for a long time in orthodontics, but is now gradually being introduced in OSAS treatment to envisage optimal treatment selection as well as to predict treatment outcomes. The purpose of the present review is to evaluate the contribution of cephalometry in the prediction of outcomes from OSAS treatments that depend on the upper airway morphology in their mechanisms of action such as oral appliances that advance the mandible as well as various surgical methods. In addition, an overview of imaging modalities and methods that currently are being used in cephalometric analysis in OSAS patients is provided. The findings indicate that isolated cephalometric parameters cannot be used to reliably predict treatment outcomes from mandibular advancement devices and surgical methods for OSAS. Extreme or outlying values of cephalometric parameters may rather be used as contra-indicators or 'red flags' instead of predictors.

Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial.

IMPORTANCE: Oral appliances that move the mandible forward during sleep are suggested as treatment for mild to moderate obstructive sleep apnea. OBJECTIVE: To test whether an adjustable, custom-made oral appliance improves daytime sleepiness and quality of life in patients with daytime sleepiness and snoring or mild to moderate obstructive sleep apnea. DESIGN, SETTING, AND PARTICIPANTS: Ninety-six patients with daytime sleepiness and an apnea-hypopnea index (AHI) lower than 30 were included in a randomized, placebo-controlled, parallel trial in Umeå, Sweden, from May 2007 through August 2011. INTERVENTIONS: Four months' intervention with an oral appliance or a placebo device. MAIN OUTCOMES AND MEASURES: Daytime sleepiness was measured with the Epworth Sleepiness Scale, the Karolinska Sleepiness Scale, and the Oxford Sleep Resistance (OSLER) test. Quality of life was assessed with the Short-Form 36-Item Health Survey (SF-36) and the Functional Outcomes of Sleep Questionnaire (FOSQ). Secondary outcomes included the apnea-hypopnea index, headaches, symptoms of restless legs, and insomnia. RESULTS: Oral appliance therapy was not associated with improvements in daytime sleepiness from baseline to 4-month follow-up when compared with the placebo device; Epworth score >10: 53% at baseline to 24% at follow-up for the oral appliance group vs 54% at baseline to 40% at follow-up for the placebo device group, P = .11; median (IQR) for Karolinska score ≥7/wk: 10 (8 to 14) at baseline to 7 (4 to 9) at follow-up for the oral appliance group vs 12 (6 to 15) at baseline to 8 (5 to 12) at follow-up for the placebo device group, P = .11; mean between-group difference in OSLER test, -2.4 min (95% CI, -6.3 to 1.4). The mean between-group difference for the total FOSQ score was insignificant (-1.2 [95% CI, -2.5 to 0.1]). No domain of the SF-36 differed significantly between the groups. The AHI was below 5 in 49% of patients using the active appliance and in 11% using placebo, with an odds ratio of 7.8 (95% CI, 2.6-23.5) and a number needed to treat of 3. Snoring (P < .001) and symptoms of restless legs (P = .02) were less frequent when using the oral appliance vs placebo, but this did not apply to headache or insomnia. CONCLUSIONS AND RELEVANCE: A custom-made, adjustable oral appliance reduces obstructive sleep apnea, snoring, and possibly restless legs without effects on daytime sleepiness and quality of life among patients with daytime sleepiness and snoring or mild to moderate sleep apnea. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00477009.

Treatment of snoring and obstructive sleep apnea with mandibular repositioning appliances.

Snoring and obstructive sleep apnea form part of a spectrum of sleep disordered breathing affecting a significant proportion of the general population and particularly the middle aged. The consequences can be severe and even life threatening for both the individual directly affected and those more remotely involved. Adverse sequelae can manifest themselves acutely or in the longer term as a result of obstructive breathing induced hypersomnolence, neurocognitive deficits and cardiovascular abnormalities. The combination of anatomical and neuromuscular risk factors in the pathogenesis of OSA has resulted in a varied approach to its management. One such treatment option is mandibular repositioning appliances (MRA), which mechanically stabilize the airway. Whilst the efficacy of this simple intervention has been rigorously proven quite recently in a significant proportion of patients with varying disease severity, individual patient selection in its application remains uncertain. Short-term side-effects are common but usually transient, whilst in the long-term minor permanent adverse developments on the dentition and occlusion have been reported. Considering both the medicolegal implications of snoring and OSA and the increasing popularity of MRA, it is recommended that skilled multidisciplinary respiratory and dental personnel form the primary care team.