Life-style Changes in Obstructive Sleep Apnea

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102920
• Other study ID #: K2008-70X-20838-01-3 PÅ
• Secondary ID: UU OSA
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: November 6, 2017
• Start date: May 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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)

Locations

Country	Name	City	State
Sweden	Uppsala University and University Hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	The Swedish Research Council, Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daytime sleepiness	Epworths sleepiness scale	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Attention and concentration	COWAT; Repetition of figures from WAIS	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Health-related quality of life	SF-36	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Patients' priorities of daily activities and participation	The Patient Goal Priority Questionnaire	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Physical activity	Sensewear armband; Physical activity diary	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Functional physical capacity	6 minutes walking distance	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Eating behaviour	Dutch eating behaviour questionnaire	Baseline, immediate post-treatment, 18-month follow-up
Secondary	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
Secondary	Anthropometrics	BMI; Waist measurement; Neck circumference	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Depression	MADRS Depression scale	Baseline, immediate post-treatment, 18-month follow-up
Secondary	Fear of movement	Selected items from the Tampa Scale of Kinesiophobia	Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
Secondary	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