CPAP, Nutrition & Exercise Against Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This study evaluates the addition of a comprehensive lifestyle program including dietary management and exercise to continuous positive airway pressure (CPAP) therapy in overweighted adults with obstructive sleep apnea. Half of the participants will receive CPAP therapy while the other half will have diet consultations, nordic walking sessions and CPAP.

Detailed Description
-----------------
While the specific impact of obstructive sleep apnea (OSA) on quality of life is well established, the impact of CPAP therapy on quality of life remains unclear. Yet, improving the quality of life of OSA patient is one of the main targets of treatment. Both exercise and healthy diet are recommended in the management of overweight and obesity. This should improve quality of life as well as comorbidities associated with sleep apnea.

Official Title
-----------------
Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP

Conditions
-----------------
Sleep Apnea, Overweight and Obesity

Intervention / Treatment
-----------------
* Other: Tailored intervention
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients newly diagnosed for obstructive sleep apnea and requiring CPAP therapy BMI>25and≤40kg/m2 Low physical activity (< 150 min of MVPA per week) IAH≥15 Able to give informed consent as documented by signature Exclusion Criteria: Patients already treated for OSA or another sleep disorder Required use of supplemental oxygen Active infection, malignancy or chronic inflammatory disorders More than moderate alcohol use of > 14 drinks per week Severe depression defined by a BDI > 30 Surgery within the previous 3 months Known cardiac or pulmonary disease contraindicating exercise training Patient with a bariatric surgery project or already operated Pregnant or lactating women Onset of a severe cardiac disease contraindicating exercise training Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, peripheral functional limitation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicentric, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored intervention<br>In this group, participants will receive a comprehensive lifestyle program in addition to CPAP therapy which will include a supervised exercise program, diet interventions and behavioural counselling during 12 weeks. Then, participants will follow a real-world maintenance program from weeks 12 to 24. It will include one telephone-based contact per month with the study coordinator. Participants will be encouraged to maintain their lifestyle modification during this phase. | Other: Tailored intervention<br>* The exercise program consists of 2 x 1.5-hour supervised nordic walking sessions weekly during 12 weeks and 1-hour unsupervised moderate physical activity per week from week 4. The diet intervention includes one face-to-face consultation with a dietician and one telephone-based contact monthly, i.e. 6 diet interventions for 12 weeks. Behavioural changes techniques will be included in diet and exercise interventions.<br>* Other names: TINE;|
| Active Comparator: Control<br>Participant in this group will benefit from routine CPAP therapy management from week 0 to 24. | Other: Control<br>* This intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation.<br>* Other names: CPAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life: SF-36 | Mean difference in the general health perception (GH) domain on the Medical Outcome Study Short Form (SF-36) between groups | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General quality of life: SF-36 | Mean difference in the seven other following SF-36 subscales between groups: Vitality (VT) physical functioning (PF) bodily pain (BP) Role-physical (RP) Role-emotionale (RE) Social functioning (SF) Mental health (MH) Each subscale ranges from 0 to 100. The higher the score, the better quality of life. | 12 and 24 weeks | 
| Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI) | Mean difference in the SAQLI global score and score in the domain A, B, C and D between groups. The SAQLI is a 35-items instrument that captures the adverse impact of sleep apnea on 4 domains: Daily functioning (A) Social interactions (B) Emotional functioning (C) Symptoms (D) When the SAQLI is administered after a therapeutic intervention, a fifth domain (E) is completed (Treatment-related symptoms). Items are scored on a 7-point scale with all of the time and not at all being the most extreme responses. Item and domain scores are averaged to yield a composite total score between 1 and 7. Higher scores represent better quality of life. To obtain the global SAQLI score the sum of the mean domain scores A, B, C, and D is divided by 4. If Domain E has been used after a therapeutic intervention, the SAQLI score is obtained by summing the mean domain scores A, B, C, and D, subtracting the mean Domain E score and dividing by 4. | 12 and 24 weeks | 
| Daytime excessive sleepiness | Mean difference in the Epworth Sleepiness Scale (ESS) score between groups. The ESS is a 8-item questionnaire. ESS score can range from 0 to 24. The higher the ESS score, the higher daytime sleepiness. | 12 and 24 weeks | 
| Subjective sleep quality | Mean difference in the Pittsburgh Sleep Quality Index (PSQI) score between groups. The PSQI is a 19-item questionnaire which measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by summing the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | 12 and 24 weeks | 
| Mood | Mean difference in the Hospital Anxiety Depression Scale (HADS) score between groups. The HADS is a 14-item questionnaire. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3. Scores range from 0 to 21 for either anxiety or depression. The higher the scores, the more anxiety and depression symptoms are important. | 12 and 24 weeks | 
| Depression | Mean difference in the Beck depression inventory (BDI) score between groups. The BDI is a 21-item questionnaire which assess the severity of depression. Score range from 0 to 63. Higher values represent a worse outcome. | 12 and 24 weeks | 
| Fatigue | Mean difference in the Pichot scale score between groups. The Pichot Scale is a 8-item questionnaire to assess fatigue. The score ranges from 0 to 32. Higher score indicates greater fatigue. | 12 and 24 weeks | 
| Blood pressure | Mean difference in systolic and diastolic blood pressure measured at office as well as via a 24-h ambulatory blood pressure monitoring | 12 and 24 weeks | 
| Weight | Mean difference in weight (kg) between groups | 12 and 24 weeks | 
| Height | Mean difference in height (m) between groups | 12 and 24 weeks | 
| Body-mass index (BMI) | Mean difference in BMI (kg.m^2) between groups. Weight will be divided by the square of the height to report BMI in kg/m^2. | 12 and 24 weeks | 
| Waist circumference | Mean difference in waist size (cm) between groups | 12 and 24 weeks | 
| Hip circumference | Mean difference in hip size (cm) between groups | 12 and 24 weeks | 
| Waist-hip ratio | Mean difference in waist/hip ratio between groups | 12 and 24 weeks | 
| Neck size | Mean difference in neck circumference (cm) between groups | 12 and 24 weeks | 
| Fat distribution | Mean difference in fat-free mass and fat mass measured via bioimpedance analysis between groups | 12 and 24 weeks | 
| Resting metabolism | Mean difference in basal metabolic rate (BMR) between groups using indirect calorimetry | 12 and 24 weeks | 
| Concentration of fasting glucose | Mean difference in fasting glucose (mg/dL) between groups | 12 and 24 weeks | 
| Rate of glycosylated haemoglobin | Mean difference in glycosylated haemoglobin [HbA1c] (%) between groups | 12 and 24 weeks | 
| Concentration of insulin | Mean difference in insulin (mlU/L) between groups | 12 and 24 weeks | 
| Concentration of total cholesterol | Mean difference in total cholesterol (g/L) between groups | 12 and 24 weeks | 
| Concentration of HDL cholesterol | Mean difference in HDL cholesterol (g/L) between groups | 12 and 24 weeks | 
| Concentration of LDL cholesterol | Mean difference in LDL cholesterol (g/L) between groups | 12 and 24 weeks | 
| Concentration of triglycerides | Mean difference in triglycerides (g/L) between groups | 12 and 24 weeks | 
| Concentration of ultrasensible CRP | Mean difference in CRP-US (mg/L) between groups | 12 and 24 weeks | 
| Respiratory events | Mean difference in apnea-hypopnea index (AHI) during sleep between groups measured via ambulatory polygraphy | 12 and 24 weeks | 
| Desaturation events | Mean difference in oxygen desaturation index (ODI) during sleep between groups measured via ambulatory polygraphy | 12 and 24 weeks | 
| T90% | Mean difference in percentage time spent with an oxygen saturation (SpO2) < 90% (T90%) during sleep between groups using an oximeter. | 12 and 24 weeks | 
| Nocturnal hypoxic load | Mean difference in hypoxic load related to apnea-hypopnea events and to sleep stages between groups using an ambulatory polygraphy. The area under the desaturation curve (SpO2) associated with respiratory-events will be used to quantify the 'hypoxic load'. | 12 and 24 weeks | 
| Autonomic Arousal Index (Aai) | Mean difference in pulse wave amplitude (PWA) drop during sleep between groups using an ambulatory polygraphy | 12 and 24 weeks | 
| Autonomic Arousal Area under the curve | Mean difference in the sum of the autonomic arousal area under the curve (AUC) between groups using an ambulatory polygraphy | 12 and 24 weeks | 
| Autonomic Arousal duration | Mean difference in the sum of the duration of the PWA drops between groups using an ambulatory polygraphy | 12 and 24 weeks | 
| CPAP withdrawal | Proportion of CPAP withdrawal in each arms | 12 and 24 weeks | 
| CPAP adherence | Mean duration of CPAP use per night in each arms | 12 and 24 weeks | 
| CPAP compliance | Proportion of compliant patients (mean CPAP use > 4h per night) in each arm | 12 and 24 weeks | 
| Medical visit | Mean number of medical visits between groups | 12 and 24 weeks | 
| Sedentary behaviour | Mean difference in sedentary time (min per day) between groups using accelerometer | 12 and 24 weeks | 
| Light physical activity (LPA) behaviour | Mean difference in LPA time (min per day) between groups using accelerometer | 12 and 24 weeks | 
| Moderate to vigorous physical activity | Mean difference in MVPA (METs-min per week) between groups using accelerometer | 12 and 24 weeks | 
| Exercise capacity | Mean difference in the distance (m) on the incremental shuttle walking test (ISWT) between groups | 12 and 24 weeks | 
| Postural stability | Mean difference in balance stability (total displacement of the centre of pressure) between groups using a posturographic platform | 12 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, CPAP therapy, exercise, diet, quality of life