Life-style Changes in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Obesity

• Registration Number: NCT01102920
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Study Start: 2010-05
• Primary Completion: 2012-03
• Study Completion: 2014-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilatory parameters	Baseline, immediate post-treatment, 18-month follow-up	Ventilatory monitoring at night. Oxygen saturation continuously measured by a pulse oximeter. The following parameters are analysed: * desaturation index; * apnoea-hypnoea index; * average oxygen saturation during sleep; * minimum oxigen saturation; * respiration; * thoracic respiratory movements; * snoring; * heart rate; * body position

Secondary Outcome Measures

Name	Time	Method
Attention and concentration	Baseline, immediate post-treatment, 18-month follow-up	* COWAT; * Repetition of figures from WAIS
Physical activity	Baseline, immediate post-treatment, 18-month follow-up	* Sensewear armband; * Physical activity diary
Functional physical capacity	Baseline, immediate post-treatment, 18-month follow-up	6 minutes walking distance
Eating behaviour	Baseline, immediate post-treatment, 18-month follow-up	Dutch eating behaviour questionnaire
Anthropometrics	Baseline, immediate post-treatment, 18-month follow-up	* BMI; * Waist measurement; * Neck circumference
Depression	Baseline, immediate post-treatment, 18-month follow-up	MADRS Depression scale
Health-related quality of life	Baseline, immediate post-treatment, 18-month follow-up	SF-36
Patients' priorities of daily activities and participation	Baseline, immediate post-treatment, 18-month follow-up	The Patient Goal Priority Questionnaire
Self-efficacy and readiness to change behaviour	Baseline, mid-treatment, immediate post-treatment, 18-month follow-up	* Exercise self-efficacy scale; * Self-efficacy for sound eating habits; * Readiness to change behaviour
Fear of movement	Baseline, mid-treatment, immediate post-treatment, 18-month follow-up	Selected items from the Tampa Scale of Kinesiophobia
Blood sample	Baseline, immediate post-treatment, 18-month follow-up	* CRP; * TNF-alfa; * lgF-1; * Hb; * HbA1C; * s-cholesterol, HDL, LDL, s-triglycerids; * K, Na; * Creatinin, Leptin, Sysozym, n-terminal pBNP
Daytime sleepiness	Baseline, immediate post-treatment, 18-month follow-up	Epworths sleepiness scale

Trial Locations

Locations (1)

Uppsala University and University Hospital; 🇸🇪 Uppsala, Sweden