CPAP, Nutrition & Exercise Against Sleep Apnea

NCT03959280 | Unknown DMC

• 1 other identifier: 2019-00586
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sleep Apnea; Overweight and Obesity

Keywords

obstructive sleep apnea; CPAP therapy; exercise; diet; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (41)

• General quality of life: SF-36

  12 and 24 weeks

• Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI)

  12 and 24 weeks

• Daytime excessive sleepiness

  12 and 24 weeks

• Subjective sleep quality

  12 and 24 weeks

• Mood

  12 and 24 weeks

Study Arms (2)

Tailored intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Participant in this group will benefit from routine CPAP therapy management from week 0 to 24.

Other: Control

Interventions

Tailored intervention OTHER

* 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.

Also known as: TINE

Tailored intervention

Control OTHER

This intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation.

Also known as: CPAP

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Raphael Heinzer: lead
• Swiss Lung Association: collaborator
• Ligue Pulmonaire Vaudoise: collaborator

Study Sites (2)

Centre Hospitalier Universitaire Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

Related Links

• Website of the Ligue Pulmonaire Vaudoise

MeSH Terms

Conditions

Sleep Apnea Syndromes; Overweight; Obesity; Sleep Apnea, Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Raphael Heinzer, MD, PhD

  University Hospital of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu Berger, PhD

CONTACT

+41 21 314 86 45; mathieu.berger@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: Prospective, multicentric, randomized controlled trial

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 22, 2019
• Study Start: August 21, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); FR (1)