Clinical trial NCT01102920: Life-style Changes in Obstructive Sleep Apnea
Official title: Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Obesity
Keywords: Obstructive sleep apnea
Obesity
Behavioural medicine
Physical therapy
Health behaviour change
Physical activity
Eating habits
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Uppsala County Council, Sweden
First posted: 2010-04-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ventilatory parameters
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
Secondary outcomes:
measure: Daytime sleepiness
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Attention and concentration
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Health-related quality of life
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Patients' priorities of daily activities and participation
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Physical activity
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Functional physical capacity
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Eating behaviour
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Self-efficacy and readiness to change behaviour
timeFrame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
measure: Anthropometrics
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Depression
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
measure: Fear of movement
timeFrame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
measure: Blood sample
timeFrame: Baseline, immediate post-treatment, 18-month follow-up
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University and University Hospital
Study officials:
affiliation: Department of Neuroscience, Uppsala University
name: Pernilla Åsenlöf, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sporndly-Nees S, Asenlof P, Lindberg E, Emtner M, Igelstrom H. Effects on obstructive sleep apnea severity following a tailored behavioral sleep medicine intervention aimed at increased physical activity and sound eating: an 18-month follow-up of a randomized controlled trial. J Clin Sleep Med. 2020 May 15;16(5):705-713. doi: 10.5664/jcsm.8322. Epub 2020 Feb 6.