Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data.

STUDY OBJECTIVES: Mandibular advancement devices (MADs) are an alternative to continuous positive airway pressure for the management of obstructive sleep apnea (OSA). The ORthèse d'avanCée mAndibulaire dans le traitement en DEuxième intention du SAHOS sévère (ORCADES) study is investigating the long-term effectiveness of MAD therapy in patients with OSA who refused or were intolerant of continuous positive airway pressure. Five-year follow-up data are presented. METHODS: Data were available in 172 of 331 patients treated with a custom-made computer-aided design/computer-aided manufacturing biblock MAD (Narval CC; ResMed, Saint-Priest, France). The primary end point was treatment success (≥50% decrease in apnea-hypopnea index from baseline). RESULTS: Five-year treatment success rates were 52% overall and 25%, 52%, and 63%, respectively, in patients with mild, moderate, or severe OSA. This reflects a decline over time vs 3-6 months (79% overall) and 2 years (68%). Rates declined in all patient subgroups but to the greatest extent in patients with mild OSA. The slight worsening of respiratory parameters over time was not associated with any relevant changes in sleepiness and symptoms. Moderate or severe OSA at baseline, treatment success at 3-6 months, and no previous continuous positive airway pressure use were significant independent predictors of 5-year treatment success on multivariate analysis. No new safety signals emerged during long-term follow-up. The proportion of patients using their MAD for ≥4 h/night on ≥4 days/wk was 93.3%; 91.3% of patients reported device use of ≥6 h/night at 5 years. At 5-year follow-up, 96.5% of patients reported that they wanted to continue MAD therapy. CONCLUSIONS: Long-term MAD therapy remained effective after 5 years in >50% of patients, with good levels of patient satisfaction and adherence. CITATION: Vecchierini MF, Attali V, Collet JM, et al. Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. J Clin Sleep Med. 2021;17(8):1695-1705.

Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data.

OBJECTIVE/BACKGROUND: Mandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The Orkney Complex Disease Study-ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in obstructive sleep apnoea syndrome (OSAS); two-year follow-up data are presented. PATIENTS/METHODS: OSAS patients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3-6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI]). RESULTS: Of 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI <5/h, <10/h and <15/h was achieved in 30%, 56% and 72% of patients, respectively. On multivariate analysis, ≥50% decrease in AHI at 3-6 months and absence of nocturia at 3-6 months were significant predictors of MRD treatment continuation. Adverse events were generally mild, and the majority occurred in the first year of treatment. CONCLUSIONS: Two years' treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP.

Development of a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination.

INTRODUCTION: A new approach to treat obstructive sleep apnea (OSA) is upper airway stimulation therapy (UAS). Electrical pulses applied to the hypoglossal nerve induce tongue protrusion, increase airway patency and decrease the frequency of apneic and hypopneic events. Thus, the main objective of this study was to design a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination. METHOD: This study has designed the Tongue Adverse Event and Satisfaction Questionnaire (TAESQ) and an endobuccal examinations divided into an endobuccal lesion examination (ELE) and an endobuccal risk factor examination (ERFE). Evaluations were conducted at month 6 post-implantation. RESULTS: The study population after implantation of UAS device consisted of ten Caucasian males with a mean age of 51.9 ± 11.8 years, and a mean BMI of 28.6 ± 3.3. The AHI of the ten participants ranged from 46.7 ± 12.2/h at baseline to 14.5 ± 8.9/h with the Inspire therapy at the 6-month follow-up. The TAESQ revealed pain (30%), followed by less tongue sensitivity (20%) and tongue weakness (10%). The ELE did not reveal any lesions. The ERFE revealed that some participants had tissue and dental risk factors but not associated to more adverse events. CONCLUSION: The TAESQ, ELE and ERFE have been designed and studied on a small number of participants. These evaluations could systematically be included in the care pathway of patients treated by UAS to better investigate tongue discomfort and tongue lesion for patients treated with this technology.

A French update on the Self-Efficacy Measure for Sleep Apnea (SEMSA) to assess continuous positive airway pressure (CPAP) use.

PURPOSE: The Self-Efficacy Measure for Sleep Apnea (SEMSA) is a 26-item self-questionnaire composed of three factors: risk perception of obstructive sleep apnea syndrome (OSAS), benefit of continuous positive airway pressure (CPAP), and self-efficacy (the confidence to engage in CPAP use). It is used to evaluate health beliefs about OSAS and CPAP in order to optimize CPAP use. The purpose of this study was to design and validate a French version of the SEMSA. METHODS: A forward-backward translation of the SEMSA was performed. Subjects with OSAS treated by CPAP and followed by our sleep clinic were invited to complete the questionnaire. The psychometric properties of the French SEMSA version were analyzed in terms of its construct validity (with confirmatory factor analysis, CFA), internal structural validity (Cronbach's alpha coefficient), and external validity (Pearson's correlation between SEMSA score and duration of CPAP use). RESULTS: Two hundred eighty-eight subjects filled in the questionnaire. The mean age was 63.16 ± 12.73 years. The number of years since the beginning of CPAP treatment was 6.58 ± 6.03 years. The mean CPAP use duration was 6.19 ± 2.03 h/night. CFA was unsatisfactory (RMSEA = 0.066 and CFI = 0.88). The exploratory factor analysis revealed a fourth factor named "cardiovascular risk" factor. Cronbach's alpha coefficient was 0.886. The correlation between the "self-efficacy" factor and the duration of CPAP use was significant (r = 0.26, p ≤ 0.001). CONCLUSIONS: The French version of the SEMSA is a psychometrically acceptable self-report questionnaire for measuring health beliefs and behavior in French patients with OSAS treated with CPAP. Such translation and validation should lead to the adoption of validated psychosocial methods for improving CPAP use.

Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome.

PURPOSE: Mandibular repositioning devices (MRDs) are an effective treatment option for obstructive sleep apnea syndrome (OSAS), particularly in patients who refuse or cannot tolerate continuous positive airway pressure (CPAP). However, sex differences in the response to therapy and predictors of response are not clearly defined. This analysis of data from the long-term prospective ORCADES trial compared MRD efficacy in men and women with OSAS. METHODS: The ORCADES study included patients with newly diagnosed mild-to-moderate or severe OSAS who refused or were non-compliant with CPAP. MRD therapy was titrated over 3-6 months. The primary endpoint was treatment success (≥ 50% decrease in apnea-hypopnea index (AHI)). Complete response was defined using a range of AHI cut-off values (< 5/h, < 10/h, < 15/h). RESULTS: Overall treatment success rates were 89% in women and 76% in men (p = 0.019); corresponding rates in those with severe OSAS (AHI > 30/h) were 100% and 68% (p = 0.0015). In women vs. men, overall complete response rates at AHI cut-off values of < 5/h, <10/h, and < 15/h were 49 vs. 34% (p = 0.0052), 78 vs. 62% (p = 0.016), and 92 vs. 76% (p = 0.0032). On multivariate analysis, significant predictors of MRD treatment success were overbite and baseline apnea index in men, and neck circumference and no previous CPAP therapy in women. There were sex differences in the occurrence of side effects. Temporomandibular joint pain was the most common reason for stopping MRD therapy. CONCLUSIONS: MRD therapy was effective in women with OSA of any severity, with significantly higher response rates compared with men especially in severe OSAS. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01326143).

Hypoglossal nerve stimulation on sleep and level of alertness in OSA: A preliminary study.

OBJECTIVES: To quantify the effect of hypoglossal nerve stimulation (HNS), a novel therapy for patients with obstructive sleep apnea, on objective level of alertness (measured with Maintenance of Wakefulness Test [MWT] values) and nocturnal sleep architecture. METHODS: Ten male patients (mean age 52.0 ± 9.4 years; mean body mass index 28.8 ± 3.3 kg/m2) noncompliant to continuous positive airway pressure received HNS (Inspire therapy) and were prospectively evaluated at baseline and 6 months after HNS therapy. Polysomnographic parameters (sleep breathing and sleep architecture) and objective level of alertness (MWT) were measured. RESULTS: The mean preimplantation apnea-hypopnea index of 46.7/h ± 12.2/h was reduced to 14.5/h ± 8.9/h at 6 months postimplantation (p < 0.001). The mean MWT latency improved from 25.0 ± 12.8 minutes at baseline to 36.8 ± 7.0 minutes after 6 months of treatment (p = 0.004). A reduction of N1% (11.8 ± 10.6 vs 4.2 ± 1.9, p = 0.04) was observed. The reduction in the duration of wake after sleep onset (WASO) was 71.4 ± 32.4 minutes vs 53.4 ± 13.5 minutes (p = 0.06) but was not significant. MWT latencies at 6 months were negatively correlated with the intensity of stimulation (r = -0.63, p = 0.05). Intensity of stimulation was positively correlated with WASO (r = 0.76, p = 0.01). CONCLUSION: HNS improved the objective level of alertness and changed nocturnal sleep architecture. The level of neural stimulation determines the amount of nocturnal WASO and the level of objective level of alertness.

Specific insomnia symptoms and self-efficacy explain CPAP compliance in a sample of OSAS patients.

This study explores the association between specific insomnia symptoms (sleep onset, sleep maintenance and early morning awakenings symptoms) and self-efficacy (perceived self-confidence in the ability to use CPAP) with CPAP compliance in French patients with obstructive sleep apnea syndrome (OSAS). We performed a retrospective, cross-sectional analysis of CPAP compliance in a cohort of 404 patients diagnosed with OSAS. Patients completed mailed questionnaires on sleepiness (ESS), insomnia (ISI) and self-efficacy in sleep apnea (SEMSA). Linear regression modeling analyses were performed to explore the impact of measured variables on the number of hours of CPAP use. Of the initial pool of 404 patients, 288 returned the questionnaires (71% response rate). Their mean age was 63.16±12.73 yrs, 31% were females, mean BMI was 30.39±6.31 kg/m2, mean daily CPAP use was 6.19±2.03 h, mean number of years of use was 6.58±6.03 yrs, and mean initial AHI before CPAP use was 34.61±20.71 /h. Age (p<0.01), BMI (p<0.01), sleep onset insomnia symptoms (p<0.01), sleep maintenance insomnia symptoms (p<0.01) and self-efficacy (p<0.01) were significantly associated with mean daily CPAP use. We found that specific insomnia symptoms and self-efficacy were associated with CPAP compliance. Our findings underline the need to demonstrate that interventions that reduce insomnia symptoms and improve self-efficacy will increase CPAP compliance.

[Implantable nerve stimulation for obstructive sleep apnea hypopnea syndrome]. / Traitement du syndrome d'apnées et hypopnées obstructives du sommeil par stimulation nerveuse implantable.

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common disorder that has been identified as a contributor to cardiovascular disease making it a major public health problem. Continuous positive airway pressure is the standard treatment but compliance is suboptimal. Mandibular advancement devices and surgery have limited indications, inconstant efficiency and potential irreversible side effects. Stimulation of the hypoglossal nerve, that innervates the genioglossus, a protrusor muscle of the tongue, is now a new treatment option for moderate and severe cases of OSAHS. Two types of stimulation are currently available: stimulation synchronous with inspiration and continuous stimulation. The indication of each type of stimulation and long-term effects still need to be assessed but the implantable nerve stimulation is a promising treatment for patients without a therapy solution so far.

A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study.

BACKGROUND: Mandibular repositioning devices (MRDs) are usually recommended as the first therapy option in patients with mild-to-moderate obstructive sleep apnoea (OSA). However, data on the long-term efficacy of MRDs are limited, not only in OSA patients who are noncompliant with continuous positive airway pressure (CPAP) but also in those with more severe OSA. The ORCADES study aimed to prospectively determine the long-term efficacy and tolerability of two custom-made Narval(™) MRDs for obstructive sleep apnoea-hypopnoea syndrome (OSAHS) patients. The interim 3- to 6-month data are reported. METHODS: Eligible patients had OSAHS and had refused or were noncompliant with prescribed CPAP. Outcome measurements after gradual mandibular advancement titration included: apnoea-hypopnoea index (AHI), oxygen saturation, sleepiness, symptoms, quality of life, side effects and compliance. RESULTS: A total of 369 patients were included. Overall, MRD treatment was successful (≥50% decrease in AHI) in 76.2% of the participants; complete response (AHI <10/h) was achieved in 63.5%. Severe OSAHS was effectively treated (AHI <15/h) in about 60% of the participants; 38% had complete symptom resolution. Mandibular repositioning devices significantly decreased subjective sleepiness, eliminated symptoms and improved quality of life. They were well tolerated and compliance was excellent. Only 8% of the participants stopped MRD treatment due to side effects. CONCLUSION: Custom-made Narval(™) MRDs are effective for mild to severe OSA in patients who refuse or are noncompliant with CPAP. They are well tolerated and have excellent compliance.

Teenage sleep-disordered breathing: recurrence of syndrome.

OBJECTIVES: The study aims to better understand the reappearance of sleep apnoea in adolescents considered cured of obstructive sleep apnoea (OSA) following adenotonsillectomy and orthodontic treatment. STUDY DESIGN: The study employs a retrospective analysis of 29 adolescents (nine girls and 20 boys) with OSA previously treated with adenotonsillectomy and orthodontia at a mean age of 7.5years. During follow-up at 11 and 14years of age, patients were clinically evaluated, filled the Pediatric Sleep Questionnaire (PSQ) and had systematic cephalometric X-rays performed by orthodontists. Polysomnographic (PSG) data were compared at the time of OSA diagnosis, following surgical and orthodontic treatment and during pubertal follow-up evaluation. RESULTS: Following the diagnosis of OSA and treatment with adenotonsillectomy and rapid maxillary expansion (Apnea-Hypopnea Index (AHI) 0.4±0.4), children were re-evaluated at a mean age of 11years. During follow-up at 14years, all children had normal body mass indices (BMIs). Teenagers were subdivided into two groups based on complaints: Nine asymptomatic subjects (seven girls and two boys) and 20 subjects with decline in school performance, presence of fatigue, indicators of sleep-phase delays and, less frequently, specific symptoms of daytime sleepiness and snoring. Presence of mouth breathing, abnormal AHI and RDI and significant reduction of posterior airway space (PAS) was demonstrated during repeat polysomnography and cephalometry. Compared to cephalometry obtained at a mean of 11years of age, there was a significant reduction of PAS of 2.3±0.4mm at a mean age of 14years. CONCLUSION: Previously suggested recurrence of OSA during teenage years has again been demonstrated in this small group of subjects. Prospective investigations are needed to establish frequency of risk, especially in non-orthodontically treated children.

Adeno-tonsillectomy and rapid maxillary distraction in pre-pubertal children, a pilot study.

INTRODUCTION: When both narrow maxilla and moderately enlarged tonsils are present in children with obstructive sleep apnea, the decision of which treatment to do first is unclear. A preliminary randomized study was done to perform a power analysis and determine the number of subjects necessary to have an appropriate response. Thirty-one children, 14 boys, diagnosed with OSA based on clinical symptoms and polysomnography (PSG) findings had presence of both narrow maxillary complex and enlarged tonsils. They were scheduled to have both adeno-tonsillectomy and RME for which the order of treatment was randomized: group 1 received surgery followed by orthodontics, while group 2 received orthodontics followed by surgery. Each child was seen by an ENT, an orthodontist, and a sleep medicine specialist. The validated pediatric sleep questionnaire and PSG were done at entry and after each treatment phase at time of PSG. Statistical analyses were ANOVA repeated measures and t tests. RESULTS: The mean age of the children at entry was 6.5 ± 0.2 years (mean ± SEM). Overall, even if children presented improvement of both clinical symptoms and PSG findings, none of the children presented normal results after treatment 1, at the exception of one case. There was no significant difference in the amount of improvement noted independently of the first treatment approach. Thirty children underwent treatment 2, with an overall significant improvement shown for PSG findings compared to baseline and compared to treatment 1, without any group differences. CONCLUSION: This preliminary study emphasizes the need to have more than subjective clinical scales for determination of sequence of treatments.