Life-style Changes in Obstructive Sleep Apnea

NCT01102920 | Completed

• 2 other identifiers: K2008-70X-20838-01-3 PÅUU OSA
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To study associations of changes in metabolic parameters and systemic inflammation and physical activity level and adherence to CPAP-regimen respectively.
4. 4.To identify mediators, moderators, and predictors of treatment effects, if any.

Conditions

Sleep Apnea, Obstructive; Obesity

Keywords

Obstructive sleep apnea; Obesity; Behavioural medicine; Physical therapy; Health behaviour change; Physical activity; Eating habits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Daytime sleepiness

  Baseline, immediate post-treatment, 18-month follow-up

• Attention and concentration

  Baseline, immediate post-treatment, 18-month follow-up

• Health-related quality of life

  Baseline, immediate post-treatment, 18-month follow-up

• Patients' priorities of daily activities and participation

  Baseline, immediate post-treatment, 18-month follow-up

• Physical activity

  Baseline, immediate post-treatment, 18-month follow-up

Study Arms (2)

Tailored behavioural treatment and CPAP

EXPERIMENTAL

Tailored behavioural treatment targeting physical activity and eating habits.

Behavioral: Behavioural strategies to promote physical activity and weight loss

CPAP-treatment

ACTIVE COMPARATOR

CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.

Device: CPAP

Interventions

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.

Tailored behavioural treatment and CPAP

CPAP DEVICE

CPAP-treatment as usual (during nights)

CPAP-treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate or severe obstructive sleep apnea syndrome (AHI/DI\>15)
• BMI\>30
• Literate in Swedish language

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (1)

Uppsala University and University Hospital

Uppsala, 751 24, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32024584 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Pernilla Åsenlöf, Professor

  Department of Neuroscience, Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2014
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

SE (1)