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Completed

NCT Number: NCT01102920

Life-style Changes in Obstructive Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Behavior Behavior, Animal Body Weight Dyssomnias Feeding Behavior Motor Activity Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University and University Hospital

Uppsala, 751 24, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioural strategies to promote physical activity and weight loss

Behavioral

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.

CPAP

Device

CPAP-treatment as usual (during nights)

Primary outcomes

  1. Ventilatory parameters

    Time frame: 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 outcomes

  1. Daytime sleepiness

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    Epworths sleepiness scale

  2. Attention and concentration

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    • COWAT
    • Repetition of figures from WAIS

  3. Health-related quality of life

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    SF-36

  4. Patients' priorities of daily activities and participation

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    The Patient Goal Priority Questionnaire

  5. Physical activity

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    • Sensewear armband
    • Physical activity diary

  6. Functional physical capacity

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    6 minutes walking distance

  7. Eating behaviour

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    Dutch eating behaviour questionnaire

  8. Self-efficacy and readiness to change behaviour

    Time frame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up

    • Exercise self-efficacy scale
    • Self-efficacy for sound eating habits
    • Readiness to change behaviour

  9. Anthropometrics

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    • BMI
    • Waist measurement
    • Neck circumference

  10. Depression

    Time frame: Baseline, immediate post-treatment, 18-month follow-up

    MADRS Depression scale

  11. Fear of movement

    Time frame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up

    Selected items from the Tampa Scale of Kinesiophobia

  12. Blood sample

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • The Swedish Research Council
  • Uppsala County Council, Sweden

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Apr 13, 2010
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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