Life-style Changes in Obstructive Sleep Apnea

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Swedish Research Council
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01102920
First received: April 12, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention
Sleep Apnea, Obstructive
Obesity
Behavioral: Behavioural strategies to promote physical activity and weight loss
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Ventilatory parameters [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]

    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:
  • Daytime sleepiness [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    Epworths sleepiness scale

  • Attention and concentration [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    • COWAT
    • Repetition of figures from WAIS

  • Health-related quality of life [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    SF-36

  • Patients' priorities of daily activities and participation [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    The Patient Goal Priority Questionnaire

  • Physical activity [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    • Sensewear armband
    • Physical activity diary

  • Functional physical capacity [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    6 minutes walking distance

  • Eating behaviour [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    Dutch eating behaviour questionnaire

  • Self-efficacy and readiness to change behaviour [ Time Frame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    • Exercise self-efficacy scale
    • Self-efficacy for sound eating habits
    • Readiness to change behaviour

  • Anthropometrics [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    • BMI
    • Waist measurement
    • Neck circumference

  • Depression [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    MADRS Depression scale

  • Fear of movement [ Time Frame: Baseline, mid-treatment, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    Selected items from the Tampa Scale of Kinesiophobia

  • Blood sample [ Time Frame: Baseline, immediate post-treatment, 18-month follow-up ] [ Designated as safety issue: No ]
    • CRP
    • TNF-alfa
    • lgF-1
    • Hb
    • HbA1C
    • s-cholesterol, HDL, LDL, s-triglycerids
    • K, Na
    • Creatinin, Leptin, Sysozym, n-terminal pBNP


Estimated Enrollment: 140
Study Start Date: May 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102920

Locations
Sweden
Uppsala University and University Hospital
Uppsala, Sweden, 751 24
Sponsors and Collaborators
Uppsala University
The Swedish Research Council
Uppsala County Council, Sweden
Investigators
Principal Investigator: Pernilla Åsenlöf, Ass Professor Department of Neuroscience, Uppsala University
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01102920     History of Changes
Other Study ID Numbers: K2008-70X-20838-01-3 PÅ, UU OSA
Study First Received: April 12, 2010
Last Updated: October 11, 2012
Health Authority: Sweden: EPN Regionala etikprövningsnämnden Uppsala

Keywords provided by Uppsala University:
Obstructive sleep apnea
Obesity
Behavioural medicine
Physical therapy
Health behaviour change
Physical activity
Eating habits

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Obesity
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 16, 2014