Mild obstructive sleep apnoea in females: post hoc analysis of the MERGE randomised controlled trial.

Background: A post hoc analysis of the MERGE trial was conducted, to investigate whether sex differences are evident at the mildest end of the disease spectrum, for symptoms associated with obstructive sleep apnoea (OSA) and the response to continuous positive airway pressure (CPAP) treatment. Methods: MERGE participants with mild OSA (apnoea-hypopnoea index 5-15 events·h-1; American Academy of Sleep Medicine 2012 criteria) were randomised to either CPAP plus standard care (sleep hygiene counselling) or standard care alone for 3 months. Quality of life (QoL) was measured by questionnaires completed before and after the 3 months. This post hoc analysis of participants of the MERGE trial compared the symptom presentation, and response to CPAP, between the sexes. Results: 233 patients were included; 71 (30%) were female. Females were more symptomatic at baseline in all QoL questionnaires. Specifically, females had lower 36-item Short-Form Health Survey (SF-36) Vitality scores (mean±sd 39.1±10.1 versus 44.8±10.3) and higher Epworth Sleepiness Scale (ESS) scores (mean±sd 11.0±4.2 versus 9.5±4.4). Both sexes experienced snoring, but more females reported fatigue and more males reported witnessed apnoeas. All symptoms improved with CPAP for both sexes; however, females had larger improvements in SF-36 Vitality scores, which was the primary outcome of the MERGE trial (mean change 9.4 (95% CI 6.8-12.0) versus 6.0 (95% CI 4.3-7.7); p=0.034), and ESS (mean change -4.1 (95% CI -5.1- -3.0) versus -2.5 (95% CI -3.1- -1.8); p=0.015), after adjustment for baseline scores and CPAP usage. Conclusions: Sex differences are apparent in patients with mild OSA. Females experience worse QoL symptoms than males at presentation to the sleep clinic; however, these improve significantly with CPAP treatment.

Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial.

BACKGROUND: The evidence base for the treatment of mild obstructive sleep apnoea is limited and definitions of disease severity vary. The MERGE trial investigated the clinical effectiveness of continuous positive airway pressure in patients with mild obstructive sleep apnoea. METHODS: MERGE, a multicentre, parallel, randomised controlled trial enrolled patients (≥18 years to ≤80 years) with mild obstructive sleep apnoea (apnoea-hypopnoea index [AHI] ≥5 to ≤15 events per h using either AASM 2007 or AASM 2012 scoring criteria) from 11 UK sleep centres. Participants were assigned (1:1) to either 3 months of continuous positive airway pressure plus standard care (sleep counselling), or standard care alone, by computer-generated randomisation; neither participants nor researchers were blinded. The primary outcome was a change in the score on the Short Form-36 questionnaire vitality scale in the intention-to-treat population of patients with mild obstructive sleep apnoea diagnosed using the American Academy of Sleep Medicine 2012 scoring criteria. The study is registered with ClinicalTrials.gov, NCT02699463. FINDINGS: Between Nov 28, 2016 and Feb 12, 2019, 301 patients were recruited and randomised. 233 had mild obstructive sleep apnoea using AASM 2012 criteria and were included in the intention-to-treat analysis: 115 were allocated to receive continuous positive airway pressure and 118 to receive standard care. 209 (90%) of these participants completed the trial. The vitality score significantly increased with a treatment effect of a mean of 10·0 points (95% CI 7·2-12·8; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (9·2 points [6·8 to 11·6] vs -0·8 points [-3·2 to 1·5]). Using the ANCOVA last-observation-carried-forward analysis, a more conservative estimate, the vitality score also significantly increased with a treatment effect of a mean of 7·5 points (95% CI 5·3 to 9·6; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (7·5 points [6·0 to 9·0] vs 0·0 points [-1·5 to 1·5]). Three serious adverse events occurred (one allocated to the continuous positive airway pressure group) and all were unrelated to the intervention. INTERPRETATION: 3 months of treatment with continuous positive airway pressure improved the quality of life in patients with mild obstructive sleep apnoea. These results highlight the need for health-care professionals and providers to consider treatment for patients with mild obstructive sleep apnoea. FUNDING: ResMed Ltd.

Novel Approach to Simulate Sleep Apnea Patients for Evaluating Positive Pressure Therapy Devices.

Bench testing is a useful method to characterize the response of different automatic positive airway pressure (APAP) devices under well-controlled conditions. However, previous models did not consider the diversity of obstructive sleep apnea (OSA) patients' characteristics and phenotypes. The objective of this proof-of-concept study was to design a new bench test for realistically simulating an OSA patient's night, and to implement a one-night example of a typical female phenotype for comparing responses to several currently-available APAP devices. We developed a novel approach aimed at replicating a typical night of sleep which includes different disturbed breathing events, disease severities, sleep/wake phases, body postures and respiratory artefacts. The simulated female OSA patient example that we implemented included periods of wake, light sleep and deep sleep with positional changes and was connected to ten different APAP devices. Flow and pressure readings were recorded; each device was tested twice. The new approach for simulating female OSA patients effectively combined a wide variety of disturbed breathing patterns to mimic the response of a predefined patient type. There were marked differences in response between devices; only three were able to overcome flow limitation to normalize breathing, and only five devices were associated with a residual apnea-hypopnea index of <5/h. In conclusion, bench tests can be designed to simulate specific patient characteristics, and typical stages of sleep, body position, and wake. Each APAP device behaved differently when exposed to this controlled model of a female OSA patient, and should lead to further understanding of OSA treatment.

Evaluation of a new pediatric positive airway pressure mask.

STUDY OBJECTIVES: The choice and variety of pediatric masks for continuous positive airway pressure (CPAP) is limited in the US. Therefore, clinicians often prescribe modified adult masks. Until recently a mask for children aged < 7 years was not available. This study evaluated apnea-hypopnea index (AHI) equivalence and acceptability of a new pediatric CPAP mask for children aged 2-7 years (Pixi; ResMed Ltd, Sydney, Australia). METHODS: Patients aged 2-7 years were enrolled and underwent in-lab baseline polysomnography (PSG) using their previous mask, then used their previous mask and the VPAP III ST-A flow generator for ≥ 10 nights at home. Thereafter, patients switched to the Pixi mask for ≥ 2 nights before returning for a PSG during PAP therapy via the Pixi mask. Patients then used the Pixi mask at home for ≥ 21 nights. Patients and their parents/guardians returned to the clinic for follow-up and provided feedback on the Pixi mask versus their previous mask. RESULTS: AHI with the Pixi mask was 1.1 ± 1.5/h vs 2.6 ± 5.4/h with the previous mask (p = 0.3538). Parents rated the Pixi mask positively for: restfulness of the child's sleep, trouble in getting the child to sleep, and trouble in having the child stay asleep. The Pixi mask was also rated highly for leaving fewer or no marks on the upper lip and under the child's ears, and being easy to remove. CONCLUSIONS: The Pixi mask is suitable for children aged 2-7 years and provides an alternative to other masks available for PAP therapy in this age group.

Assessment of the performance of nasal pillows at high CPAP pressures.

STUDY OBJECTIVES: Compliance with CPAP therapy remains an issue despite its effectiveness. Mask selection is likely to affect a patients experience with CPAP, and multiple mask options are currently available. Nasal pillows have less contact with the face compared to nasal masks and may benefit patients by minimizing side effects; however, they are infrequently used at high CPAP pressures. The aim of this study was to examine the performance of nasal pillows at pressures ≥ 12 cm H2O compared with nasal masks. METHODS: Twenty-one subjects were recruited. Participants were randomized to Swift FX nasal pillows and their current nasal mask for 7 consecutive nights each in a prospective crossover trial. Objective device data and subjective feedback were collected. RESULTS: There were no differences in objective device data of nasal pillows vs. nasal masks: Daily Usage 7.4 ± 1.4 vs. 7.2 ± 1.4 (h/night); 95(th)%ile Leak 28.6 ± 13.5 vs. 27.9 ± 17.9 (L/min); AHI 1.9 ± 1.3 vs. 1.7 ± 1.1, respectively (all p-values > 0.05). There were no differences between the nasal pillows and nasal masks for subjective ratings of comfort, seal, red marks, side effects such as jetting and dry nose/mouth, and overall performance (all p-values > 0.05). The nasal pillows were rated to be less obtrusive and claustrophobic (both p-values < 0.01), but less stable (p = 0.04). Overall preference was 50% nasal pillows, 45% nasal masks; 5% found no difference. CONCLUSION: Nasal pillows are as efficacious as nasal masks at CPAP pressures ≥ 12 cm H2O and are a suitable option for patients requiring high CPAP pressures. CLINICAL TRIAL REGISTRATION: NIH Clinical Trials Registry. http://clinicaltrials.gov. TITLE: Nasal Pillows at High CPAP Pressure. Identifier: NCT01690923.

Assessment of the impact on compliance of a new CPAP system in obstructive sleep apnea.

BACKGROUND: Despite the efficacy of continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA), compliance with therapy remains suboptimal.The aim of this study was to determine whether the use of S9TM increased compliance in established CPAP users. METHODS: Subjects with OSA (50) were recruited into the study. When subjects entered the study, 28 days of respective compliance data were downloaded from the patient's usual CPAP device. Subjects trialled the S9 CPAP for 28 days.Subjects then resumed use of their usual CPAP for 28 days.Compliance data from the patient's usual CPAP pre- and post-trialling S9 were compared with data from the S9 CPAP. RESULTS: Patients were significantly more compliant when using the S9 than their usual CPAP device both pre- and post-S9 based on average daily usage. CPAP pre-S906.58±1.95(mean hours±SD), S907.08±1.18 h and CPAP post-S906.71±1.72 h. The difference between CPAP pre-S9 and S9 was 0.5 h (p00.003). The difference between S9 and CPAP post-S9 was 0.35 h (p00.01). There was no significant difference between CPAP pre-S9 and CPAP post-S9 (p00.34).Patients also completed questionnaires comparing the S9 system to their usual device. Subjective feedback showed a strong preference for the S9. CONCLUSIONS: Participants were significantly more compliant when using the S9 than their usual CPAP device both pre and post-S9 use