CPAP, Nutrition & Exercise Against Sleep Apnea

NCT ID: NCT03959280

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2022-12-31

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.

Conditions

Sleep Apnea; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tailored intervention

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Tailored intervention

• 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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Other Intervention Names

TINE; CPAP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Lung Association

UNKNOWN

Sponsor Role: collaborator

Ligue Pulmonaire Vaudoise

UNKNOWN

Sponsor Role: collaborator

Raphael Heinzer

OTHER

Sponsor Role: lead

Responsible Party

Raphael Heinzer

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Raphael Heinzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lausanne, Switzerland

Locations

Centre Hospitalier Universitaire Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status: RECRUITING

Countries

France; Switzerland

Central Contacts

Mathieu Berger, PhD

Role: CONTACT

mathieu.berger@chuv.ch

+41 21 314 86 45

Facility Contacts

Arnauld Garcin, MSc

Role: primary

arnauld.garcin@chu-st-etienne.fr

+33477120286

Mathieu Berger, PhD

Role: primary

mathieu.berger@chuv.ch

+41 21 314 86 45

Related Links

https://www.liguepulmonaire.ch/fr/ligue-pulmonaire-vaudoise/page-daccueil.html

Website of the Ligue Pulmonaire Vaudoise

Other Identifiers

2019-00586

Identifier Type: -

Identifier Source: org_study_id