Overview

This trial is active, not recruiting.

Conditions sleep apnea, obstructive, obesity
Treatments behavioural strategies to promote physical activity and weight loss, cpap
Sponsor Uppsala University
Collaborator The Swedish Research Council
Start date May 2010
End date December 2012
Trial size 140 participants
Trial identifier NCT01102920, K2008-70X-20838-01-3 PÅ, UU OSA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Tailored behavioural treatment targeting physical activity and eating habits.
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.
(Active Comparator)
CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.
cpap
CPAP-treatment as usual (during nights)

Primary Outcomes

Measure
Ventilatory parameters
time frame: Baseline, immediate post-treatment, 18-month follow-up

Secondary Outcomes

Measure
Daytime sleepiness
time frame: Baseline, immediate post-treatment, 18-month follow-up
Attention and concentration
time frame: Baseline, immediate post-treatment, 18-month follow-up
Health-related quality of life
time frame: Baseline, immediate post-treatment, 18-month follow-up
Patients' priorities of daily activities and participation
time frame: Baseline, immediate post-treatment, 18-month follow-up
Physical activity
time frame: Baseline, immediate post-treatment, 18-month follow-up
Functional physical capacity
time frame: Baseline, immediate post-treatment, 18-month follow-up
Eating behaviour
time frame: Baseline, immediate post-treatment, 18-month follow-up
Self-efficacy and readiness to change behaviour
time frame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
Anthropometrics
time frame: Baseline, immediate post-treatment, 18-month follow-up
Depression
time frame: Baseline, immediate post-treatment, 18-month follow-up
Fear of movement
time frame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
Blood sample
time frame: Baseline, immediate post-treatment, 18-month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Moderate or severe obstructive sleep apnea syndrome (AHI/DI>15) - BMI>30 - Literate in Swedish language Exclusion Criteria: - Physically active patients (walking, bicycling for more than 30 minutes per day,during more than 5 days per week) - Cardiovascular diseases including myocardial infarctions and stroke - Patients on waiting list for gastric by-pass

Additional Information

Official title Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.
Principal investigator Pernilla Åsenlöf, Ass Professor
Description OSAS is characterised by loud snoring, upper airway obstruction, and occasional apnea during sleep. OSAS may affect at least 4% of the men and 2% of the women in middle-age. In Sweden, prevalence figures of 200 000 have been reported. The mechanisms behind OSAS is not fully explained but functionally impaired upper airways muscles, causing a reduction in tonic and phasic contraction during sleep, are proposed one key explanation. The reduced contractions cause partial or complete occlusion of airflow, which in turn cause oxygen desaturation and sleep fragmentation. Patients commonly report everyday life consequences including loud snoring, sleep disturbances, daytime sleepiness, reduced alertness and concentration, and involvement in motor vehicle accidents. Between 7% and 70% of patients suffer from depression and anxiety (figures vary extensively because of methodological differences in existing studies). Due to cardiovascular consequences, OSAS is also linked to hypertension, myocardial infarction, and stroke. Approximately 75% of patients with severe OSAS carry overweight. First line measures recommended for OSAS are conservative including lifestyle modifications, CPAP, and oral appliances. Current state-of-science concludes that CPAP is best possible evidence-based treatment. Despite the use of life style modification recommendations in terms of physical activity and weight loss in accepted guidelines of OSAS, randomised clinical trials supporting these recommendations are rare. Hence, the value of health behaviour modifications has yet to be established. Research within this area is therefore of major interest and urgency, which has motivated the present study design.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Uppsala University.