Sleep ApneaTINENCT03959280
CPAP, Nutrition & Exercise Against Sleep Apnea
A study testing Tailored intervention in people with Sleep Apnea and Overweight and Obesity, run by Raphael Heinzer at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Overweight and Obesity
- What is being tested?
- Tailored intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Aug 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Saint-Etienne
Saint-Etienne, 42055
Arnauld Garcin, MSc, +33477120286, arnauld.garcin@chu-st-etienne.fr
Frédéric Roche, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Mathieu Berger, PhD, +41 21 314 86 45, mathieu.berger@chuv.ch
Raphael Heinzer, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Tailored intervention, Control
- Keywords
- obstructive sleep apnea, CPAP therapy, exercise, diet, quality of life
- Medical subject headings
- Sleep Apnea Syndromes, Overweight, Obesity, Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored interventionOther
Also called TINE
- 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.
ControlOther
Also called CPAP
This intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tailored intervention |
| Control | Active comparator | Participant in this group will benefit from routine CPAP therapy management from week 0 to 24. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (41)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 and 24 weeks
Weight
Mean difference in weight (kg) between groups
Measured: 12 and 24 weeks
Height
Mean difference in height (m) between groups
Measured: 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.
Measured: 12 and 24 weeks
Waist circumference
Mean difference in waist size (cm) between groups
Measured: 12 and 24 weeks
Hip circumference
Mean difference in hip size (cm) between groups
Measured: 12 and 24 weeks
Waist-hip ratio
Mean difference in waist/hip ratio between groups
Measured: 12 and 24 weeks
Neck size
Mean difference in neck circumference (cm) between groups
Measured: 12 and 24 weeks
Fat distribution
Mean difference in fat-free mass and fat mass measured via bioimpedance analysis between groups
Measured: 12 and 24 weeks
Resting metabolism
Mean difference in basal metabolic rate (BMR) between groups using indirect calorimetry
Measured: 12 and 24 weeks
Concentration of fasting glucose
Mean difference in fasting glucose (mg/dL) between groups
Measured: 12 and 24 weeks
Rate of glycosylated haemoglobin
Mean difference in glycosylated haemoglobin [HbA1c] (%) between groups
Measured: 12 and 24 weeks
Concentration of insulin
Mean difference in insulin (mlU/L) between groups
Measured: 12 and 24 weeks
Concentration of total cholesterol
Mean difference in total cholesterol (g/L) between groups
Measured: 12 and 24 weeks
Concentration of HDL cholesterol
Mean difference in HDL cholesterol (g/L) between groups
Measured: 12 and 24 weeks
Concentration of LDL cholesterol
Mean difference in LDL cholesterol (g/L) between groups
Measured: 12 and 24 weeks
Concentration of triglycerides
Mean difference in triglycerides (g/L) between groups
Measured: 12 and 24 weeks
Concentration of ultrasensible CRP
Mean difference in CRP-US (mg/L) between groups
Measured: 12 and 24 weeks
Respiratory events
Mean difference in apnea-hypopnea index (AHI) during sleep between groups measured via ambulatory polygraphy
Measured: 12 and 24 weeks
Desaturation events
Mean difference in oxygen desaturation index (ODI) during sleep between groups measured via ambulatory polygraphy
Measured: 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.
Measured: 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'.
Measured: 12 and 24 weeks
Autonomic Arousal Index (Aai)
Mean difference in pulse wave amplitude (PWA) drop during sleep between groups using an ambulatory polygraphy
Measured: 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
Measured: 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
Measured: 12 and 24 weeks
CPAP withdrawal
Proportion of CPAP withdrawal in each arms
Measured: 12 and 24 weeks
CPAP adherence
Mean duration of CPAP use per night in each arms
Measured: 12 and 24 weeks
CPAP compliance
Proportion of compliant patients (mean CPAP use > 4h per night) in each arm
Measured: 12 and 24 weeks
Medical visit
Mean number of medical visits between groups
Measured: 12 and 24 weeks
Sedentary behaviour
Mean difference in sedentary time (min per day) between groups using accelerometer
Measured: 12 and 24 weeks
Light physical activity (LPA) behaviour
Mean difference in LPA time (min per day) between groups using accelerometer
Measured: 12 and 24 weeks
Moderate to vigorous physical activity
Mean difference in MVPA (METs-min per week) between groups using accelerometer
Measured: 12 and 24 weeks
Exercise capacity
Mean difference in the distance (m) on the incremental shuttle walking test (ISWT) between groups
Measured: 12 and 24 weeks
Postural stability
Mean difference in balance stability (total displacement of the centre of pressure) between groups using a posturographic platform
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start21 Aug 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicentric, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raphael Heinzer
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Lung Association, Ligue Pulmonaire Vaudoise
- Responsible party
- Sponsor-investigator, Raphael Heinzer, Centre Hospitalier Universitaire Vaudois
- Investigators
- Raphael Heinzer, MD, PhD, Principal investigator, University Hospital of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959280
- Sponsor's protocol ID
- 2019-00586
- Other IDs
- 2019
- Acronym
- TINE
- Status last verified
- Aug 2021
- First submitted
- 14 May 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP
- ClinicalTrials.gov ID
- NCT03959280
- Acronym / sponsor ID
- TINE / 2019-00586
- Conditions
- Sleep Apnea, Overweight and Obesity
- Keywords
- obstructive sleep apnea, CPAP therapy, exercise, diet, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Raphael HeinzerUniversity, hospital or other
- Collaborators
- Swiss Lung Association, Ligue Pulmonaire Vaudoise
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentric, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tailored intervention | Experimental | Other: Tailored interventionIn 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. |
| Control | Active comparator | Other: ControlParticipant in this group will benefit from routine CPAP therapy management from week 0 to 24. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored interventionAlso: TINE* 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 | Tailored intervention |
| ControlAlso: CPAPThis intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation. | Other | Control |
Primary outcome
Health-related quality of life: SF-36
Time frame: 12 weeks
Mean difference in the general health perception (GH) domain on the Medical Outcome Study Short Form (SF-36) between groups
41 secondary outcomes
General quality of life: SF-36
Time frame: 12 and 24 weeks
Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI)
Time frame: 12 and 24 weeks
Daytime excessive sleepiness
Time frame: 12 and 24 weeks
Subjective sleep quality
Time frame: 12 and 24 weeks
Mood
Time frame: 12 and 24 weeks
Depression
Time frame: 12 and 24 weeks
Fatigue
Time frame: 12 and 24 weeks
Blood pressure
Time frame: 12 and 24 weeks
Weight
Time frame: 12 and 24 weeks
Height
Time frame: 12 and 24 weeks
Body-mass index (BMI)
Time frame: 12 and 24 weeks
Waist circumference
Time frame: 12 and 24 weeks
Hip circumference
Time frame: 12 and 24 weeks
Waist-hip ratio
Time frame: 12 and 24 weeks
Neck size
Time frame: 12 and 24 weeks
Fat distribution
Time frame: 12 and 24 weeks
Resting metabolism
Time frame: 12 and 24 weeks
Concentration of fasting glucose
Time frame: 12 and 24 weeks
Rate of glycosylated haemoglobin
Time frame: 12 and 24 weeks
Concentration of insulin
Time frame: 12 and 24 weeks
Concentration of total cholesterol
Time frame: 12 and 24 weeks
Concentration of HDL cholesterol
Time frame: 12 and 24 weeks
Concentration of LDL cholesterol
Time frame: 12 and 24 weeks
Concentration of triglycerides
Time frame: 12 and 24 weeks
Concentration of ultrasensible CRP
Time frame: 12 and 24 weeks
Respiratory events
Time frame: 12 and 24 weeks
Desaturation events
Time frame: 12 and 24 weeks
T90%
Time frame: 12 and 24 weeks
Nocturnal hypoxic load
Time frame: 12 and 24 weeks
Autonomic Arousal Index (Aai)
Time frame: 12 and 24 weeks
Autonomic Arousal Area under the curve
Time frame: 12 and 24 weeks
Autonomic Arousal duration
Time frame: 12 and 24 weeks
CPAP withdrawal
Time frame: 12 and 24 weeks
CPAP adherence
Time frame: 12 and 24 weeks
CPAP compliance
Time frame: 12 and 24 weeks
Medical visit
Time frame: 12 and 24 weeks
Sedentary behaviour
Time frame: 12 and 24 weeks
Light physical activity (LPA) behaviour
Time frame: 12 and 24 weeks
Moderate to vigorous physical activity
Time frame: 12 and 24 weeks
Exercise capacity
Time frame: 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Heinzer, MD, PhD principal investigator
University Hospital of Lausanne, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored intervention in people with Sleep Apnea and Overweight and Obesity, run by Raphael Heinzer at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Berger, PhD (+41 21 314 86 45, mathieu.berger@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life: SF-36 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.