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Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study.

ABSTRACT: Many patients with obstructive sleep apnoea (OSA) remain undiagnosed and thus untreated, and in part this relates to delay in diagnosis. Novel diagnostic strategies may improve access to diagnosis. In a multicentre, randomised study, we evaluated time to treatment decision in patients referred for suspected OSA, comparing a mandibular movement (MM) monitor to respiratory polygraphy, the most commonly used OSA detection method in the UK. Adults with high pre-test probability OSA were recruited from both northern Scotland and London. 40 participants (70 % male, mean±SD age 46.8 ± 12.9 years, BMI 36.9 ± 7.5 kg/m², ESS 14.9 ± 4.1) wore a MM monitor and respiratory polygraphy simultaneously overnight and were randomised (1:1) to receive their treatment decision based on results from either device. Compared to respiratory polygraphy, MM monitor reduced time to treatment decision by 6 days (median(IQR): 13.5 (7.0-21.5) vs. 19.5 (13.7-35.5) days, P = 0.017) and saved an estimated 29 min of staff time per patient.

SUBMITTER: Alsaif SS

PROVIDER: S-EPMC11345283 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study.

Alsaif Sulaiman S SS Douglas Wendy W Steier Joerg J Morrell Mary J MJ Polkey Michael I MI Kelly Julia L JL

Clinical medicine (London, England) 20240722 4

Many patients with obstructive sleep apnoea (OSA) remain undiagnosed and thus untreated, and in part this relates to delay in diagnosis. Novel diagnostic strategies may improve access to diagnosis. In a multicentre, randomised study, we evaluated time to treatment decision in patients referred for suspected OSA, comparing a mandibular movement (MM) monitor to respiratory polygraphy, the most commonly used OSA detection method in the UK. Adults with high pre-test probability OSA were recruited fr ...[more]

PMID: 39047815

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Project description:BackgroundObstructive sleep apnoea (OSA) is a sleep-related breathing disorder characterised by the repeated episodic collapse of the upper airway during sleep, resulting in sleep deprivation, giving rise to apnoeas and hypopnoeas. Based on the severity of OSA, there are two primary treatment modalities, continuous positive airway pressure (CPAP) and mandibular advancement appliances (MAA); both are adherence-dependent. MAA is offered to those with mild to moderate OSA and is prescribed as an alternative to patients intolerable to CPAP. However, adherence to MAA treatment is variable and declines over time. Hence, the current study aims to assess the effectiveness of the stage-matched intervention, the Health Action Process Approach (HAPA), on adherence to MAA in patients with OSA.MethodsA single-centre randomised clinical trial will be undertaken at Bart's Health NHS Trust. Fifty-six participants with newly diagnosed OSA are planned to be enrolled in the study and randomised to intervention care (IC) and standardised care (SC) groups. Participants in the SC group will receive routine care whilst participants in the IC group will receive the stage-matched intervention, developed using the HAPA model. Data indicating MAA adherence will be collected both objectively and subjectively, from micro-sensors embedded in the MAA design and sleep diaries, respectively at 3, 6, 18 and 36 months. In addition, a range of questionnaires designed to assess risk perception, outcome expectancy, and self-efficacy (SEMSA) and quality of sleep (PSQI and ESS) and life (EQ-5DL), socio-economic and social support scales will be used.DiscussionThe currently available treatments for obstructive sleep apnoea depend entirely on the patient's acceptance and use. There are several factors that affect cooperation and wear for example patients' awareness of their condition, social support and psychological behaviour. In addition, mood, such as anxiety, stress, and depression, may affect wear. At the same time, we know that interventions involving more education and behaviour approaches can help patients adapt more easily to some treatments. As a result, the present trial aims to explore the potential role of these factors to maximise treatment success and minimise side effects.Trial registrationClinicalTrials.gov NCT04092660 . Registered on September 6, 2019.

Project description:BackgroundThe capacity to diagnose obstructive sleep apnoea (OSA) must be expanded to meet an estimated disease burden of nearly one billion people worldwide. Validated alternatives to the gold standard polysomnography (PSG) will improve access to testing and treatment. This study aimed to evaluate the diagnosis of OSA, using measurements of mandibular movement (MM) combined with automated machine learning analysis, compared to in-home PSG.Methods40 suspected OSA patients underwent single overnight in-home sleep testing with PSG (Nox A1, ResMed, Australia) and simultaneous MM monitoring (Sunrise, Sunrise SA, Belgium). PSG recordings were manually analysed by two expert sleep centres (Grenoble and London); MM analysis was automated. The Obstructive Respiratory Disturbance Index calculated from the MM monitoring (MM-ORDI) was compared to the PSG (PSG-ORDI) using intraclass correlation coefficient and Bland-Altman analysis. Receiver operating characteristic curves (ROC) were constructed to optimise the diagnostic performance of the MM monitor at different PSG-ORDI thresholds (5, 15, and 30 events/hour).Results31 patients were included in the analysis (58% men; mean (SD) age: 48 (15) years; BMI: 30.4 (7.6) kg/m2). Good agreement was observed between MM-ORDI and PSG-ORDI (median bias 0.00; 95% CI -23.25 to + 9.73 events/hour). However, for 15 patients with no or mild OSA, MM monitoring overestimated disease severity (PSG-ORDI < 5: MM-ORDI mean overestimation + 5.58 (95% CI + 2.03 to + 7.46) events/hour; PSG-ORDI > 5-15: MM-ORDI overestimation + 3.70 (95% CI -0.53 to + 18.32) events/hour). In 16 patients with moderate-severe OSA (n = 9 with PSG-ORDI 15-30 events/h and n = 7 with a PSG-ORD > 30 events/h), there was an underestimation (PSG-ORDI > 15: MM-ORDI underestimation -8.70 (95% CI -28.46 to + 4.01) events/hour). ROC optimal cut-off values for PSG-ORDI thresholds of 5, 15, 30 events/hour were: 9.53, 12.65 and 24.81 events/hour, respectively. These cut-off values yielded a sensitivity of 88, 100 and 79%, and a specificity of 100, 75, 96%. The positive predictive values were: 100, 80, 95% and the negative predictive values 89, 100, 82%, respectively.ConclusionThe diagnosis of OSA, using MM with machine learning analysis, is comparable to manually scored in-home PSG. Therefore, this novel monitor could be a convenient diagnostic tool that can easily be used in the patients' own home.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT04262557.

Dataset Information

Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study.

Publications

Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study.

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