Life-style Changes in Obstructive Sleep Apnea

Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Obesity
• Intervention / Treatment: Behavioral: Behavioural strategies to promote physical activity and weight loss; Device: CPAP

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 751 24
    • Uppsala University and University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored behavioural treatment and CPAP; Tailored behavioural treatment targeting physical activity and eating habits.	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.
Active Comparator: CPAP-treatment; CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.	Device: CPAP; CPAP-treatment as usual (during nights)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilatory parameters	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	Baseline, immediate post-treatment, 18-month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: The Swedish Research Council; Uppsala County Council, Sweden
• Investigators: Principal Investigator: Pernilla Åsenlöf, Professor, Department of Neuroscience, Uppsala University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Obstructive sleep apnea; Physical activity; Physical therapy; Eating habits; Behavioural medicine; Health behaviour change
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: K2008-70X-20838-01-3 PÅ; UU OSA (Other Identifier: Uppsala University)