Lifestyle Intervention in Obstructive Sleep Apnoea

Study Overview
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Brief Summary
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Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.

Official Title
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Effects of a Lifestyle Intervention on Quality of Life, Weight Loss and Cardiovascular Risk in Patients With Obstructive Sleep Apnoea Established on Continuous Positive Airway Pressure

Conditions
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Obstructive Sleep Apnoea, Obesity

Intervention / Treatment
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* Behavioral: Combined lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (>75% nightly use per week) clinically obese (body mass index >30) age 18-85 years able to undertake exercise testing and training Exclusion Criteria: patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries) unable to undertake the requirements of the study non-English speaking already undertaking >30 min exercise >3 times per week non-compliant with CPAP body mass index <30 unable to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care control<br>Leaflet on exercise and diet | |
| Experimental: Lifestyle intervention<br>Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet) | Behavioral: Combined lifestyle intervention<br>* Exercise training, dietary advice, behaviour change counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass |  | 25 weeks | 
| Incremental shuttle walk performance |  | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (EQ-5D and EQ-VAS) |  | 13 and 25 weeks | 
| Body fat percentage |  | 13 and 25 weeks | 
| Resting blood pressure |  | 13 and 25 weeks | 
| Blood markers (glucose, insulin, lipids, CRP) |  | 13 and 25 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, diet, lifestyle, sleep apnoea, obesity