Lifestyle Intervention for OSA in Adults

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.

Official Title
-----------------
Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional. Male patients aged between 18-65 years. Body mass index > 25 kg/m2. Use of CPAP Motivation to participate in the study. Signed informed consent form. Exclusion Criteria: Sleep disorder other than OSA Clinically significant psychiatric, neurological, or medical disorders other than OSA Use of prescription drugs or clinically significant drugs affecting sleep

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention Group (LIG)<br>Participants from this group will receive a cognitive-behavioral intervention addressing weight loss and lifestyle habits such as hypocaloric diet, moderate exercise, smoking and alcohol avoidance, and sleep hygiene. This behavioral intervention will be combined with the usual treatment for OSA, i.e. CPAP. | Behavioral: Lifestyle Intervention<br>* Cognitive-behavioural intervention for weight loss and lifestyle change<br>|
| No Intervention: Control group<br>Participants from the control group will not receive any type of intervention apart from the usual care (CPAP). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention. | Change in apnoea (airflow reduction greater than or equal to 90%) and hypopnoea (airflow reduction greater than or equal to 30%) episodes per hour of sleep, from baseline to post-intervention. | Post-intervention (2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxygen desaturation index (ODI) from baseline to post-intervention. | Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention. | Post-intervention (2 months) | 
| Change in oxygen saturation (SaO2) mean from baseline to post-intervention | Change in the average of oxygen saturation from baseline to post-intervention | Post-intervention (2 months) | 
| Change in oxygen saturation (SaO2) nadir from baseline to post-intervention | Minimum oxygen saturation from baseline to post-intervention | Post-intervention (2 months) | 
| Change in sleep efficiency from baseline to post-intervention | Change in the total sleep time/total time in bed from baseline to post-intervention | Post-intervention (2 months) | 
| Change in light sleep (N1 and N2 stages) from baseline to post-intervention | Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in deep sleep (N3 stage) from baseline to post-intervention | Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in rapid eye movement (REM) sleep from baseline to post-intervention | Change in the percentage of REM sleep from baseline to post-intervention | Post-intervention (2 months) | 
| Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention. | Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention. | Post-intervention (2 months) | 
| Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention. | Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention. | Post-intervention (2 months) | 
| Change in excessive daytime sleepiness (EDS) from baseline to post-intervention | Change in the difficulty in maintaining a desired level of wakefulness, measured by the Epworth sleepiness scale (ESS) from baseline to post-intervention. ESS is a 4-point scale (0 = no chance of dozing, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing) that measures the usual chances of dozing off or falling asleep while engaged in eight different activities. An ESS total score from 0 to 9 is considered to be normal while an ESS total score > 9 indicates high daytime sleepiness. | Post-intervention (2 months) | 
| Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. | Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. This scale includes a total of 19 self-rated items combined to form seven component scores i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), each of which has a range of 0-3 points. The sum of these seven PSQI component scores is considered to obtain a global PSQI score (ranging from 0-21), with higher scores indicating poorer sleep quality. | Post-intervention (2 months) | 
| Change in Wake After Sleep Onset (WASO) from baseline to post-intervention | Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in body weight (kg) from baseline to post-intervention | Change in body weight (kg) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in fat mass (kg) from baseline to post-intervention | Change in fat mass (kg) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in mean blood pressure (mm HG) from baseline to post-intervention | Change in mean blood pressure (mm HG) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in plasma glucose (mg/dL) from baseline to post-intervention | Change in plasma glucose (mg/dL) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in total cholesterol (mg/dL) from baseline to post-intervention | Change in total cholesterol (mg/dL) from baseline to post-intervention | Post-intervention (2 months) | 
| Change in total triglycerides (mg/dL) from baseline to post-intervention | Change in total triglycerides (mg/dL) from baseline to post-intervention | Post-intervention (2 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, weight loss, lifestyle intervention, continuous positive airway pressure, OSA, CPAP