CPAP, Nutrition & Exercise Against Sleep Apnea
- Conditions
- Overweight and ObesitySleep Apnea
- Interventions
- Other: Tailored interventionOther: Control
- Registration Number
- NCT03959280
- Lead Sponsor
- Raphael Heinzer
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tailored intervention Tailored intervention 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. Control Control Participant in this group will benefit from routine CPAP therapy management from week 0 to 24.
- Primary Outcome Measures
Name Time Method Health-related quality of life: SF-36 12 weeks Mean difference in the general health perception (GH) domain on the Medical Outcome Study Short Form (SF-36) between groups
- Secondary Outcome Measures
Name Time Method Hip circumference 12 and 24 weeks Mean difference in hip size (cm) between groups
Waist-hip ratio 12 and 24 weeks Mean difference in waist/hip ratio between groups
Neck size 12 and 24 weeks Mean difference in neck circumference (cm) between groups
Weight 12 and 24 weeks Mean difference in weight (kg) between groups
Blood pressure 12 and 24 weeks Mean difference in systolic and diastolic blood pressure measured at office as well as via a 24-h ambulatory blood pressure monitoring
Concentration of fasting glucose 12 and 24 weeks Mean difference in fasting glucose (mg/dL) between groups
Concentration of insulin 12 and 24 weeks Mean difference in insulin (mlU/L) between groups
Autonomic Arousal Area under the curve 12 and 24 weeks Mean difference in the sum of the autonomic arousal area under the curve (AUC) between groups using an ambulatory polygraphy
Autonomic Arousal duration 12 and 24 weeks Mean difference in the sum of the duration of the PWA drops between groups using an ambulatory polygraphy
Exercise capacity 12 and 24 weeks Mean difference in the distance (m) on the incremental shuttle walking test (ISWT) between groups
General quality of life: SF-36 12 and 24 weeks 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.Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI) 12 and 24 weeks 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.Height 12 and 24 weeks Mean difference in height (m) between groups
Daytime excessive sleepiness 12 and 24 weeks 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.
Subjective sleep quality 12 and 24 weeks 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.Mood 12 and 24 weeks 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.Body-mass index (BMI) 12 and 24 weeks 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.
Waist circumference 12 and 24 weeks Mean difference in waist size (cm) between groups
Rate of glycosylated haemoglobin 12 and 24 weeks Mean difference in glycosylated haemoglobin \[HbA1c\] (%) between groups
Concentration of triglycerides 12 and 24 weeks Mean difference in triglycerides (g/L) between groups
Respiratory events 12 and 24 weeks Mean difference in apnea-hypopnea index (AHI) during sleep between groups measured via ambulatory polygraphy
Desaturation events 12 and 24 weeks Mean difference in oxygen desaturation index (ODI) during sleep between groups measured via ambulatory polygraphy
Autonomic Arousal Index (Aai) 12 and 24 weeks Mean difference in pulse wave amplitude (PWA) drop during sleep between groups using an ambulatory polygraphy
CPAP withdrawal 12 and 24 weeks Proportion of CPAP withdrawal in each arms
Postural stability 12 and 24 weeks Mean difference in balance stability (total displacement of the centre of pressure) between groups using a posturographic platform
Depression 12 and 24 weeks 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.
Fatigue 12 and 24 weeks 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.
Fat distribution 12 and 24 weeks Mean difference in fat-free mass and fat mass measured via bioimpedance analysis between groups
Concentration of ultrasensible CRP 12 and 24 weeks Mean difference in CRP-US (mg/L) between groups
Nocturnal hypoxic load 12 and 24 weeks 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'.
CPAP compliance 12 and 24 weeks Proportion of compliant patients (mean CPAP use \> 4h per night) in each arm
Moderate to vigorous physical activity 12 and 24 weeks Mean difference in MVPA (METs-min per week) between groups using accelerometer
Concentration of total cholesterol 12 and 24 weeks Mean difference in total cholesterol (g/L) between groups
Concentration of LDL cholesterol 12 and 24 weeks Mean difference in LDL cholesterol (g/L) between groups
Sedentary behaviour 12 and 24 weeks Mean difference in sedentary time (min per day) between groups using accelerometer
Resting metabolism 12 and 24 weeks Mean difference in basal metabolic rate (BMR) between groups using indirect calorimetry
Concentration of HDL cholesterol 12 and 24 weeks Mean difference in HDL cholesterol (g/L) between groups
T90% 12 and 24 weeks Mean difference in percentage time spent with an oxygen saturation (SpO2) \< 90% (T90%) during sleep between groups using an oximeter.
CPAP adherence 12 and 24 weeks Mean duration of CPAP use per night in each arms
Medical visit 12 and 24 weeks Mean number of medical visits between groups
Light physical activity (LPA) behaviour 12 and 24 weeks Mean difference in LPA time (min per day) between groups using accelerometer
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Centre Hospitalier Universitaire Saint-Etienne
🇫🇷Saint-Étienne, France