CPAP, Nutrition & Exercise Against Sleep Apnea (TINE)

Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea; Overweight and Obesity
• Intervention / Treatment: Other: Tailored intervention; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu Berger, PhD; Phone Number: +41 21 314 86 45; Email: mathieu.berger@chuv.ch

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Recruiting
    • CENTRE HOSPITALIER UNIVERSITAIRE SAINT-ETIENNE
    • Contact: Arnauld Garcin, MSc; Phone Number: +33477120286; Email: arnauld.garcin@chu-st-etienne.fr
    • Principal Investigator: Frédéric Roche, MD, PhD
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois
    • Contact: Mathieu Berger, PhD; Phone Number: +41 21 314 86 45; Email: mathieu.berger@chuv.ch
    • Principal Investigator: Raphael Heinzer, MD, PhD
    • Sub-Investigator: Mathieu BERGER, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: TINE
Active Comparator: Control; Participant in this group will benefit from routine CPAP therapy management from week 0 to 24.	Other: Control; This intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation.; Other Names: CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
General quality of life: SF-36	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.	12 and 24 weeks
Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI)	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.	12 and 24 weeks
Daytime excessive sleepiness	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.	12 and 24 weeks
Subjective sleep quality	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.	12 and 24 weeks
Mood	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.	12 and 24 weeks
Depression	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.	12 and 24 weeks
Fatigue	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.	12 and 24 weeks
Blood pressure	Mean difference in systolic and diastolic blood pressure measured at office as well as via a 24-h ambulatory blood pressure monitoring	12 and 24 weeks
Weight	Mean difference in weight (kg) between groups	12 and 24 weeks
Height	Mean difference in height (m) between groups	12 and 24 weeks
Body-mass index (BMI)	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.	12 and 24 weeks
Waist circumference	Mean difference in waist size (cm) between groups	12 and 24 weeks
Hip circumference	Mean difference in hip size (cm) between groups	12 and 24 weeks
Waist-hip ratio	Mean difference in waist/hip ratio between groups	12 and 24 weeks
Neck size	Mean difference in neck circumference (cm) between groups	12 and 24 weeks
Fat distribution	Mean difference in fat-free mass and fat mass measured via bioimpedance analysis between groups	12 and 24 weeks
Resting metabolism	Mean difference in basal metabolic rate (BMR) between groups using indirect calorimetry	12 and 24 weeks
Concentration of fasting glucose	Mean difference in fasting glucose (mg/dL) between groups	12 and 24 weeks
Rate of glycosylated haemoglobin	Mean difference in glycosylated haemoglobin [HbA1c] (%) between groups	12 and 24 weeks
Concentration of insulin	Mean difference in insulin (mlU/L) between groups	12 and 24 weeks
Concentration of total cholesterol	Mean difference in total cholesterol (g/L) between groups	12 and 24 weeks
Concentration of HDL cholesterol	Mean difference in HDL cholesterol (g/L) between groups	12 and 24 weeks
Concentration of LDL cholesterol	Mean difference in LDL cholesterol (g/L) between groups	12 and 24 weeks
Concentration of triglycerides	Mean difference in triglycerides (g/L) between groups	12 and 24 weeks
Concentration of ultrasensible CRP	Mean difference in CRP-US (mg/L) between groups	12 and 24 weeks
Respiratory events	Mean difference in apnea-hypopnea index (AHI) during sleep between groups measured via ambulatory polygraphy	12 and 24 weeks
Desaturation events	Mean difference in oxygen desaturation index (ODI) during sleep between groups measured via ambulatory polygraphy	12 and 24 weeks
T90%	Mean difference in percentage time spent with an oxygen saturation (SpO2) < 90% (T90%) during sleep between groups using an oximeter.	12 and 24 weeks
Nocturnal hypoxic load	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'.	12 and 24 weeks
Autonomic Arousal Index (Aai)	Mean difference in pulse wave amplitude (PWA) drop during sleep between groups using an ambulatory polygraphy	12 and 24 weeks
Autonomic Arousal Area under the curve	Mean difference in the sum of the autonomic arousal area under the curve (AUC) between groups using an ambulatory polygraphy	12 and 24 weeks
Autonomic Arousal duration	Mean difference in the sum of the duration of the PWA drops between groups using an ambulatory polygraphy	12 and 24 weeks
CPAP withdrawal	Proportion of CPAP withdrawal in each arms	12 and 24 weeks
CPAP adherence	Mean duration of CPAP use per night in each arms	12 and 24 weeks
CPAP compliance	Proportion of compliant patients (mean CPAP use > 4h per night) in each arm	12 and 24 weeks
Medical visit	Mean number of medical visits between groups	12 and 24 weeks
Sedentary behaviour	Mean difference in sedentary time (min per day) between groups using accelerometer	12 and 24 weeks
Light physical activity (LPA) behaviour	Mean difference in LPA time (min per day) between groups using accelerometer	12 and 24 weeks
Moderate to vigorous physical activity	Mean difference in MVPA (METs-min per week) between groups using accelerometer	12 and 24 weeks
Exercise capacity	Mean difference in the distance (m) on the incremental shuttle walking test (ISWT) between groups	12 and 24 weeks
Postural stability	Mean difference in balance stability (total displacement of the centre of pressure) between groups using a posturographic platform	12 and 24 weeks

Collaborators and Investigators

• Sponsor: Raphael Heinzer
• Collaborators: Ligue Pulmonaire Vaudoise; Swiss Lung Association
• Investigators: Principal Investigator: Raphael Heinzer, MD, PhD, University Hospital of Lausanne, Switzerland

Publications and helpful links

Helpful Links

• Website of the Ligue Pulmonaire Vaudoise

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: exercise; quality of life; obstructive sleep apnea; diet; CPAP therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea; Overweight
• Other Study ID Numbers: 2019-00586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No