Ear, Nose and Throat Mental and Behavioural Disorders Respiratory Cardiology
Conditions
Interventions
Sponsors
APAC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18–75 years. Mild obstructive sleep apnoea, defined as an apnoea–hypopnoea index (AHI) =5 and =15 events·h?¹ on standard respiratory polygraphy scored according to the American Academy of Sleep Medicine (AASM) 2012 criteria. Ability to provide written informed consent. Willingness and ability to comply with the assigned intervention. Willingness and ability to use the study device nightly throughout the intervention period (Arm A only). Willingness and ability to attend all scheduled follow-up visits over the 12-month study period.
Exclusion criteria
Exclusion criteria: Previous treatment with continuous positive airway pressure (CPAP) or any other positive airway pressure therapy. Predominant central sleep apnoea, defined as a central apnoea index accounting for >50% of the total apnoea–hypopnoea index (AHI), or the presence of Cheyne–Stokes respiration. Severe excessive daytime sleepiness posing an immediate safety risk, defined as an Epworth Sleepiness Scale (ESS) score >16 or occupational driving/machine operation associated with self-reported sleepiness-related near-miss events. Myocardial infarction, unstable angina, or stroke within the preceding 3 months. Decompensated heart failure (New York Heart Association [NYHA] class IV). Chronic respiratory failure or hypoventilation syndrome requiring bilevel positive airway pressure or other ventilatory support. Body mass index (BMI) >45 kg/m². Pregnancy or planned pregnancy during the study period. Current shift work with an irregular sleep–wake schedule. Severe psychiatric illness or cognitive impairment preventing informed consent or adherence to the study protocol. Life expectancy <12 months due to a coexisting terminal illness. Participation in another interventional clinical trial within the preceding 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the between-group difference in the change in SF-36 Vitality subscale score (range 0–100, higher indicating better vitality (Guermazi et al., 2012)) from baseline to 12 months, analysed in the intention-to-treat population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary patient-reported outcomes are assessed using the ESS (Ahmed et al., 2014), the Fatigue Severity Scale (Al-Sobayel et al., 2016), the Hospital Anxiety and Depression Scale (Terkawi et al., 2017), and the EQ-5D-5L generic health-utility index (Group, 1990). Glycaemic status is summarised by the homeostasis model assessment of insulin resistance (HOMA-IR) (Matthews et al., 1985), and arterial stiffness by carotid, femoral pulse-wave velocity measured according to expert consensus methodology (Van Bortel et al., 2012). | — |
Countries
Tunisia
Contacts
Public ContactSamy Kammoun
University of Sfax Tunisia
Outcome results
None listed