CPAP, Nutrition & Exercise Against Sleep Apnea (TINE)

Raphael Heinzer

Status: Unknown

Conditions: Overweight and Obesity; Sleep Apnea

Treatments: Other: Tailored intervention; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03959280

2019-00586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Tailored intervention

Experimental group

Description:

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.

Treatment:

Other: Tailored intervention

Control

Active Comparator group

Description:

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

Treatment:

Other: Control