Back to resultsCPAP, Nutrition & Exercise Against Sleep Apnea (TINE)
Primary Purpose
Sleep Apnea, Overweight and Obesity
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tailored intervention
Control
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring obstructive sleep apnea, CPAP therapy, exercise, diet, quality of life
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.
Sites / Locations
- Centre Hospitalier Universitaire Saint-EtienneRecruiting
- Centre Hospitalier Universitaire VaudoisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored intervention
Control
Arm 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.
Participant in this group will benefit from routine CPAP therapy management from week 0 to 24.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Blood pressure
Mean difference in systolic and diastolic blood pressure measured at office as well as via a 24-h ambulatory blood pressure monitoring
Weight
Mean difference in weight (kg) between groups
Height
Mean difference in height (m) between groups
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.
Waist circumference
Mean difference in waist size (cm) between groups
Hip circumference
Mean difference in hip size (cm) between groups
Waist-hip ratio
Mean difference in waist/hip ratio between groups
Neck size
Mean difference in neck circumference (cm) between groups
Fat distribution
Mean difference in fat-free mass and fat mass measured via bioimpedance analysis between groups
Resting metabolism
Mean difference in basal metabolic rate (BMR) between groups using indirect calorimetry
Concentration of fasting glucose
Mean difference in fasting glucose (mg/dL) between groups
Rate of glycosylated haemoglobin
Mean difference in glycosylated haemoglobin [HbA1c] (%) between groups
Concentration of insulin
Mean difference in insulin (mlU/L) between groups
Concentration of total cholesterol
Mean difference in total cholesterol (g/L) between groups
Concentration of HDL cholesterol
Mean difference in HDL cholesterol (g/L) between groups
Concentration of LDL cholesterol
Mean difference in LDL cholesterol (g/L) between groups
Concentration of triglycerides
Mean difference in triglycerides (g/L) between groups
Concentration of ultrasensible CRP
Mean difference in CRP-US (mg/L) between groups
Respiratory events
Mean difference in apnea-hypopnea index (AHI) during sleep between groups measured via ambulatory polygraphy
Desaturation events
Mean difference in oxygen desaturation index (ODI) during sleep between groups measured via ambulatory polygraphy
T90%
Mean difference in percentage time spent with an oxygen saturation (SpO2) < 90% (T90%) during sleep between groups using an oximeter.
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'.
Autonomic Arousal Index (Aai)
Mean difference in pulse wave amplitude (PWA) drop during sleep between groups using an ambulatory polygraphy
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
Autonomic Arousal duration
Mean difference in the sum of the duration of the PWA drops between groups using an ambulatory polygraphy
CPAP withdrawal
Proportion of CPAP withdrawal in each arms
CPAP adherence
Mean duration of CPAP use per night in each arms
CPAP compliance
Proportion of compliant patients (mean CPAP use > 4h per night) in each arm
Medical visit
Mean number of medical visits between groups
Sedentary behaviour
Mean difference in sedentary time (min per day) between groups using accelerometer
Light physical activity (LPA) behaviour
Mean difference in LPA time (min per day) between groups using accelerometer
Moderate to vigorous physical activity
Mean difference in MVPA (METs-min per week) between groups using accelerometer
Exercise capacity
Mean difference in the distance (m) on the incremental shuttle walking test (ISWT) between groups
Postural stability
Mean difference in balance stability (total displacement of the centre of pressure) between groups using a posturographic platform
Full Information
NCT ID
NCT03959280
First Posted
May 14, 2019
Last Updated
August 5, 2021
Sponsor
Raphael Heinzer
Collaborators
Swiss Lung Association, Ligue Pulmonaire Vaudoise
1. Study Identification
Unique Protocol Identification Number
NCT03959280
Brief Title
CPAP, Nutrition & Exercise Against Sleep Apnea
Acronym
TINE
Official Title
Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raphael Heinzer
Collaborators
Swiss Lung Association, Ligue Pulmonaire Vaudoise
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Overweight and Obesity
Keywords
obstructive sleep apnea, CPAP therapy, exercise, diet, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicentric, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tailored intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participant in this group will benefit from routine CPAP therapy management from week 0 to 24.
Intervention Type
Other
Intervention Name(s)
Tailored intervention
Other Intervention Name(s)
TINE
Intervention Description
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
Intervention Name(s)
Control
Other Intervention Name(s)
CPAP
Intervention Description
This intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation.
Primary Outcome Measure Information:
Title
Health-related quality of life: SF-36
Description
Mean difference in the general health perception (GH) domain on the Medical Outcome Study Short Form (SF-36) between groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
General quality of life: SF-36
Description
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.
Time Frame
12 and 24 weeks
Title
Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI)
Description
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.
Time Frame
12 and 24 weeks
Title
Daytime excessive sleepiness
Description
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.
Time Frame
12 and 24 weeks
Title
Subjective sleep quality
Description
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.
Time Frame
12 and 24 weeks
Title
Mood
Description
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.
Time Frame
12 and 24 weeks
Title
Depression
Description
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.
Time Frame
12 and 24 weeks
Title
Fatigue
Description
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.
Time Frame
12 and 24 weeks
Title
Blood pressure
Description
Mean difference in systolic and diastolic blood pressure measured at office as well as via a 24-h ambulatory blood pressure monitoring
Time Frame
12 and 24 weeks
Title
Weight
Description
Mean difference in weight (kg) between groups
Time Frame
12 and 24 weeks
Title
Height
Description
Mean difference in height (m) between groups
Time Frame
12 and 24 weeks
Title
Body-mass index (BMI)
Description
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.
Time Frame
12 and 24 weeks
Title
Waist circumference
Description
Mean difference in waist size (cm) between groups
Time Frame
12 and 24 weeks
Title
Hip circumference
Description
Mean difference in hip size (cm) between groups
Time Frame
12 and 24 weeks
Title
Waist-hip ratio
Description
Mean difference in waist/hip ratio between groups
Time Frame
12 and 24 weeks
Title
Neck size
Description
Mean difference in neck circumference (cm) between groups
Time Frame
12 and 24 weeks
Title
Fat distribution
Description
Mean difference in fat-free mass and fat mass measured via bioimpedance analysis between groups
Time Frame
12 and 24 weeks
Title
Resting metabolism
Description
Mean difference in basal metabolic rate (BMR) between groups using indirect calorimetry
Time Frame
12 and 24 weeks
Title
Concentration of fasting glucose
Description
Mean difference in fasting glucose (mg/dL) between groups
Time Frame
12 and 24 weeks
Title
Rate of glycosylated haemoglobin
Description
Mean difference in glycosylated haemoglobin [HbA1c] (%) between groups
Time Frame
12 and 24 weeks
Title
Concentration of insulin
Description
Mean difference in insulin (mlU/L) between groups
Time Frame
12 and 24 weeks
Title
Concentration of total cholesterol
Description
Mean difference in total cholesterol (g/L) between groups
Time Frame
12 and 24 weeks
Title
Concentration of HDL cholesterol
Description
Mean difference in HDL cholesterol (g/L) between groups
Time Frame
12 and 24 weeks
Title
Concentration of LDL cholesterol
Description
Mean difference in LDL cholesterol (g/L) between groups
Time Frame
12 and 24 weeks
Title
Concentration of triglycerides
Description
Mean difference in triglycerides (g/L) between groups
Time Frame
12 and 24 weeks
Title
Concentration of ultrasensible CRP
Description
Mean difference in CRP-US (mg/L) between groups
Time Frame
12 and 24 weeks
Title
Respiratory events
Description
Mean difference in apnea-hypopnea index (AHI) during sleep between groups measured via ambulatory polygraphy
Time Frame
12 and 24 weeks
Title
Desaturation events
Description
Mean difference in oxygen desaturation index (ODI) during sleep between groups measured via ambulatory polygraphy
Time Frame
12 and 24 weeks
Title
T90%
Description
Mean difference in percentage time spent with an oxygen saturation (SpO2) < 90% (T90%) during sleep between groups using an oximeter.
Time Frame
12 and 24 weeks
Title
Nocturnal hypoxic load
Description
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'.
Time Frame
12 and 24 weeks
Title
Autonomic Arousal Index (Aai)
Description
Mean difference in pulse wave amplitude (PWA) drop during sleep between groups using an ambulatory polygraphy
Time Frame
12 and 24 weeks
Title
Autonomic Arousal Area under the curve
Description
Mean difference in the sum of the autonomic arousal area under the curve (AUC) between groups using an ambulatory polygraphy
Time Frame
12 and 24 weeks
Title
Autonomic Arousal duration
Description
Mean difference in the sum of the duration of the PWA drops between groups using an ambulatory polygraphy
Time Frame
12 and 24 weeks
Title
CPAP withdrawal
Description
Proportion of CPAP withdrawal in each arms
Time Frame
12 and 24 weeks
Title
CPAP adherence
Description
Mean duration of CPAP use per night in each arms
Time Frame
12 and 24 weeks
Title
CPAP compliance
Description
Proportion of compliant patients (mean CPAP use > 4h per night) in each arm
Time Frame
12 and 24 weeks
Title
Medical visit
Description
Mean number of medical visits between groups
Time Frame
12 and 24 weeks
Title
Sedentary behaviour
Description
Mean difference in sedentary time (min per day) between groups using accelerometer
Time Frame
12 and 24 weeks
Title
Light physical activity (LPA) behaviour
Description
Mean difference in LPA time (min per day) between groups using accelerometer
Time Frame
12 and 24 weeks
Title
Moderate to vigorous physical activity
Description
Mean difference in MVPA (METs-min per week) between groups using accelerometer
Time Frame
12 and 24 weeks
Title
Exercise capacity
Description
Mean difference in the distance (m) on the incremental shuttle walking test (ISWT) between groups
Time Frame
12 and 24 weeks
Title
Postural stability
Description
Mean difference in balance stability (total displacement of the centre of pressure) between groups using a posturographic platform
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Berger, PhD
Phone
+41 21 314 86 45
Email
mathieu.berger@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Heinzer, MD, PhD
Organizational Affiliation
University Hospital of Lausanne, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnauld Garcin, MSc
Phone
+33477120286
Email
arnauld.garcin@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Roche, MD, PhD
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Berger, PhD
Phone
+41 21 314 86 45
Email
mathieu.berger@chuv.ch
First Name & Middle Initial & Last Name & Degree
Raphael Heinzer, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mathieu Berger, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.liguepulmonaire.ch/fr/ligue-pulmonaire-vaudoise/page-daccueil.html
Description
Website of the Ligue Pulmonaire Vaudoise
Learn more about this trial
CPAP, Nutrition & Exercise Against Sleep Apnea
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