Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea Overweight and Obesity | Other: Tailored intervention Other: Control | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, monocentric, randomized controlled trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP |
Actual Study Start Date : | August 21, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |
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
Other Name: 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 Name: CPAP
|
Mean difference in the seven other following SF-36 subscales between groups:
Each subscale ranges from 0 to 100. The higher the score, the better quality of life.
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:
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.
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.
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.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mathieu Berger, PhD | +41 21 314 86 45 | mathieu.berger@chuv.ch |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Switzerland, 1011 | |
Contact: Mathieu Berger, PhD +41 21 314 86 45 mathieu.berger@chuv.ch | |
Principal Investigator: Raphael Heinzer, MD, PhD | |
Sub-Investigator: Mathieu Berger, PhD |
Principal Investigator: | Raphael Heinzer, MD, PhD | University Hospital of Lausanne, Switzerland |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | May 14, 2019 | ||||
First Posted Date ICMJE | May 22, 2019 | ||||
Last Update Posted Date | October 26, 2020 | ||||
Actual Study Start Date ICMJE | August 21, 2019 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CPAP, Nutrition & Exercise Against Sleep Apnea | ||||
Official Title ICMJE | Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP | ||||
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, monocentric, randomized controlled trial Masking: None (Open Label)Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | Switzerland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03959280 | ||||
Other Study ID Numbers ICMJE | 2019-00586 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Raphael Heinzer, Centre Hospitalier Universitaire Vaudois | ||||
Study Sponsor ICMJE | Raphael Heinzer | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
PRS Account | Centre Hospitalier Universitaire Vaudois | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |