Life-style Changes in Obstructive Sleep Apnea
NCT01102920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2017-11-08
Summary
The primary aim is to study whether a tailored behavioural medicine intervention addressing physical activity and eating habits have additional effects to continuous positive airways pressure (CPAP) in patients with moderate or severe obstructive sleep apnea syndrome (OSAS) combined with obesity. Direct everyday life consequences (see below) of OSAS are studied, as well as cognitive functions and ventilatory parameters. Long-term benefits will be examined in terms of quality of life and everyday life activity. Another aim is to study mechanisms of treatment effects, if any.
The specific goals are:
1. To study changes in OSAS ventilatory parameters following a tailored behavioural medicine intervention addressing physical activity and eating habits (including CPAP) compared to regular CPAP-treatment
2. To study immediate and long-term effects on daytime sleepiness, attention and concentration, everyday life activity, quality of life following a tailored behavioural medicine intervention addressing physical activity and eating habits (including CPAP) compared to regular CPAP-treatment
3. To study associations of changes in metabolic parameters and systemic inflammation and physical activity level and adherence to CPAP-regimen respectively.
4. To identify mediators, moderators, and predictors of treatment effects, if any.
Conditions
- Sleep Apnea, Obstructive
- Obesity
Interventions
- BEHAVIORAL
-
Behavioural strategies to promote physical activity and weight loss
8-10 sessions, 2-4 booster sessions Behavioural protocol in seven steps to initiate, carry out and maintain health-enhancing physical activity and sound eating habits. Steps are standardized including: progressive goal setting, self-monitoring, functional behavioural analysis, skills training (basic and applied), generalization, and maintenance and relapse prevention. Content within each step is tailored to individual expectations and skills. Treatments are provided by a physical therapist and a dietician.
- DEVICE
-
CPAP
CPAP-treatment as usual (during nights)
Sponsors & Collaborators
-
The Swedish Research Council
collaborator OTHER_GOV -
Uppsala County Council, Sweden
collaborator OTHER_GOV -
Uppsala University
lead OTHER
Principal Investigators
-
Pernilla Åsenlöf, Professor · Department of Neuroscience, Uppsala University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2012-03-31
- Completion
- 2014-09-30
Countries
- Sweden
Study Locations
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