Life-style Changes in Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive, Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Behavioural strategies to promote physical activity and weight loss
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive sleep apnea, Obesity, Behavioural medicine, Physical therapy, Health behaviour change, Physical activity, Eating habits
Eligibility 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
Sites / Locations
- Uppsala University and University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored behavioural treatment and CPAP
CPAP-treatment
Arm Description
Tailored behavioural treatment targeting physical activity and eating habits.
CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Daytime sleepiness
Epworths sleepiness scale
Attention and concentration
COWAT
Repetition of figures from WAIS
Health-related quality of life
SF-36
Patients' priorities of daily activities and participation
The Patient Goal Priority Questionnaire
Physical activity
Sensewear armband
Physical activity diary
Functional physical capacity
6 minutes walking distance
Eating behaviour
Dutch eating behaviour questionnaire
Self-efficacy and readiness to change behaviour
Exercise self-efficacy scale
Self-efficacy for sound eating habits
Readiness to change behaviour
Anthropometrics
BMI
Waist measurement
Neck circumference
Depression
MADRS Depression scale
Fear of movement
Selected items from the Tampa Scale of Kinesiophobia
Blood sample
CRP
TNF-alfa
lgF-1
Hb
HbA1C
s-cholesterol, HDL, LDL, s-triglycerids
K, Na
Creatinin, Leptin, Sysozym, n-terminal pBNP
Full Information
NCT ID
NCT01102920
First Posted
April 12, 2010
Last Updated
November 6, 2017
Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01102920
Brief Title
Life-style Changes in Obstructive Sleep Apnea
Official Title
Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Uppsala County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
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
To study associations of changes in metabolic parameters and systemic inflammation and physical activity level and adherence to CPAP-regimen respectively.
To identify mediators, moderators, and predictors of treatment effects, if any.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Obesity
Keywords
Obstructive sleep apnea, Obesity, Behavioural medicine, Physical therapy, Health behaviour change, Physical activity, Eating habits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored behavioural treatment and CPAP
Arm Type
Experimental
Arm Description
Tailored behavioural treatment targeting physical activity and eating habits.
Arm Title
CPAP-treatment
Arm Type
Active Comparator
Arm Description
CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural strategies to promote physical activity and weight loss
Intervention Description
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
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP-treatment as usual (during nights)
Primary Outcome Measure Information:
Title
Ventilatory parameters
Description
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
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Secondary Outcome Measure Information:
Title
Daytime sleepiness
Description
Epworths sleepiness scale
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Attention and concentration
Description
COWAT
Repetition of figures from WAIS
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Health-related quality of life
Description
SF-36
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Patients' priorities of daily activities and participation
Description
The Patient Goal Priority Questionnaire
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Physical activity
Description
Sensewear armband
Physical activity diary
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Functional physical capacity
Description
6 minutes walking distance
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Eating behaviour
Description
Dutch eating behaviour questionnaire
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Self-efficacy and readiness to change behaviour
Description
Exercise self-efficacy scale
Self-efficacy for sound eating habits
Readiness to change behaviour
Time Frame
Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
Title
Anthropometrics
Description
BMI
Waist measurement
Neck circumference
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Depression
Description
MADRS Depression scale
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
Title
Fear of movement
Description
Selected items from the Tampa Scale of Kinesiophobia
Time Frame
Baseline, mid-treatment, immediate post-treatment, 18-month follow-up
Title
Blood sample
Description
CRP
TNF-alfa
lgF-1
Hb
HbA1C
s-cholesterol, HDL, LDL, s-triglycerids
K, Na
Creatinin, Leptin, Sysozym, n-terminal pBNP
Time Frame
Baseline, immediate post-treatment, 18-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernilla Åsenlöf, Professor
Organizational Affiliation
Department of Neuroscience, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University and University Hospital
City
Uppsala
ZIP/Postal Code
751 24
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
32024584
Citation
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.
Results Reference
derived
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Life-style Changes in Obstructive Sleep Apnea
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