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Life-style Changes in Obstructive Sleep Apnea

NCT ID: NCT01102920

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive Obesity

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tailored behavioural treatment and CPAP

Tailored behavioural treatment targeting physical activity and eating habits.

Group Type EXPERIMENTAL

Behavioural strategies to promote physical activity and weight loss

Intervention Type 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-treatment

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

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

CPAP-treatment as usual (during nights)

Interventions

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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.

Intervention Type BEHAVIORAL

CPAP

CPAP-treatment as usual (during nights)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pernilla Åsenlöf, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroscience, Uppsala University

Locations

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Uppsala University and University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 32024584 (View on PubMed)

Other Identifiers

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UU OSA

Identifier Type: OTHER

Identifier Source: secondary_id

K2008-70X-20838-01-3 PÅ

Identifier Type: -

Identifier Source: org_study_id