Clinical trial NCT03959280: CPAP, Nutrition & Exercise Against Sleep Apnea
Official title: Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Overweight and Obesity
Keywords: obstructive sleep apnea
CPAP therapy
exercise
diet
quality of life
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Swiss Lung Association
name: Ligue Pulmonaire Vaudoise
First posted: 2019-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicentric, randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Health-related quality of life: SF-36
timeFrame: 12 weeks
Secondary outcomes:
measure: General quality of life: SF-36
timeFrame: 12 and 24 weeks
measure: Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI)
timeFrame: 12 and 24 weeks
measure: Daytime excessive sleepiness
timeFrame: 12 and 24 weeks
measure: Subjective sleep quality
timeFrame: 12 and 24 weeks
measure: Mood
timeFrame: 12 and 24 weeks
measure: Depression
timeFrame: 12 and 24 weeks
measure: Fatigue
timeFrame: 12 and 24 weeks
measure: Blood pressure
timeFrame: 12 and 24 weeks
measure: Weight
timeFrame: 12 and 24 weeks
measure: Height
timeFrame: 12 and 24 weeks
measure: Body-mass index (BMI)
timeFrame: 12 and 24 weeks
measure: Waist circumference
timeFrame: 12 and 24 weeks
measure: Hip circumference
timeFrame: 12 and 24 weeks
measure: Waist-hip ratio
timeFrame: 12 and 24 weeks
measure: Neck size
timeFrame: 12 and 24 weeks
measure: Fat distribution
timeFrame: 12 and 24 weeks
measure: Resting metabolism
timeFrame: 12 and 24 weeks
measure: Concentration of fasting glucose
timeFrame: 12 and 24 weeks
measure: Rate of glycosylated haemoglobin
timeFrame: 12 and 24 weeks
measure: Concentration of insulin
timeFrame: 12 and 24 weeks
measure: Concentration of total cholesterol
timeFrame: 12 and 24 weeks
measure: Concentration of HDL cholesterol
timeFrame: 12 and 24 weeks
measure: Concentration of LDL cholesterol
timeFrame: 12 and 24 weeks
measure: Concentration of triglycerides
timeFrame: 12 and 24 weeks
measure: Concentration of ultrasensible CRP
timeFrame: 12 and 24 weeks
measure: Respiratory events
timeFrame: 12 and 24 weeks
measure: Desaturation events
timeFrame: 12 and 24 weeks
measure: T90%
timeFrame: 12 and 24 weeks
measure: Nocturnal hypoxic load
timeFrame: 12 and 24 weeks
measure: Autonomic Arousal Index (Aai)
timeFrame: 12 and 24 weeks
measure: Autonomic Arousal Area under the curve
timeFrame: 12 and 24 weeks
measure: Autonomic Arousal duration
timeFrame: 12 and 24 weeks
measure: CPAP withdrawal
timeFrame: 12 and 24 weeks
measure: CPAP adherence
timeFrame: 12 and 24 weeks
measure: CPAP compliance
timeFrame: 12 and 24 weeks
measure: Medical visit
timeFrame: 12 and 24 weeks
measure: Sedentary behaviour
timeFrame: 12 and 24 weeks
measure: Light physical activity (LPA) behaviour
timeFrame: 12 and 24 weeks
measure: Moderate to vigorous physical activity
timeFrame: 12 and 24 weeks
measure: Exercise capacity
timeFrame: 12 and 24 weeks
measure: Postural stability
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire Saint-Etienne
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: University Hospital of Lausanne, Switzerland
name: Raphael Heinzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: