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Sleep Apnea, ObstructiveNCT01102920

Life-style Changes in Obstructive Sleep Apnea

A study testing Behavioural strategies to promote physical activity and weight loss and CPAP in people with Sleep Apnea, Obstructive and Obesity, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sleep Apnea, Obstructive, Obesity
What is being tested?
Behavioural strategies to promote physical activity and weight loss and CPAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteSweden
Study dates
May 2010to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala University and University Hospital

    Uppsala, 751 24

Other trials in Sweden

About this study

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

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.
Read the 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.

Being tested
Behavioural strategies to promote physical activity and weight loss, CPAP
Keywords
Obstructive sleep apnea, Obesity, Behavioural medicine, Physical therapy, Health behaviour change, Physical activity, Eating habits
Medical subject headings
Sleep Apnea, Obstructive, Obesity, Motor Activity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioural strategies to promote physical activity and weight lossBehavioural

    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.

  • CPAPDevice

    CPAP-treatment as usual (during nights)

Study groups in NCT01102920
Study groupRoleWhat they receive
Tailored behavioural treatment and CPAPExperimentalTailored behavioural treatment targeting physical activity and eating habits.
Receives: Behavioral: Behavioural strategies to promote physical activity and weight loss
CPAP-treatmentActive comparatorCPAP-treatment as usual. Advice about benefits of physical activity and weight loss.
Receives: Device: CPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (12)

  1. Daytime sleepiness

    Epworths sleepiness scale

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

  2. Attention and concentration

    • COWAT
    • Repetition of figures from WAIS

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

  3. Health-related quality of life

    SF-36

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

  4. Patients' priorities of daily activities and participation

    The Patient Goal Priority Questionnaire

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

  5. Physical activity

    • Sensewear armband
    • Physical activity diary

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

  6. Functional physical capacity

    6 minutes walking distance

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

  7. Eating behaviour

    Dutch eating behaviour questionnaire

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

  8. Self-efficacy and readiness to change behaviour

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

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

  9. Anthropometrics

    • BMI
    • Waist measurement
    • Neck circumference

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

  10. Depression

    MADRS Depression scale

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

  11. Fear of movement

    Selected items from the Tampa Scale of Kinesiophobia

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

  12. Blood sample

    • CRP
    • TNF-alfa
    • lgF-1
    • Hb
    • HbA1C
    • s-cholesterol, HDL, LDL, s-triglycerids
    • K, Na
    • Creatinin, Leptin, Sysozym, n-terminal pBNP

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2012
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01102920
Sponsor's protocol ID
K2008-70X-20838-01-3 PÅ
Other IDs
UU OSA
Status last verified
Nov 2017
First submitted
12 Apr 2010
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32024584

Questions about this trial

What is this clinical trial studying?

A study testing Behavioural strategies to promote physical activity and weight loss and CPAP in people with Sleep Apnea, Obstructive and Obesity, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilatory parameters (time frame: Baseline, immediate post-treatment, 18-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01102920, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.

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