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| ID | Type | Description | Link |
|---|---|---|---|
| UU OSA | Other Identifier | Uppsala University |
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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| Uppsala County Council, Sweden | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored behavioural treatment and CPAP | Experimental | Tailored behavioural treatment targeting physical activity and eating habits. |
|
| CPAP-treatment | Active Comparator | CPAP-treatment as usual. Advice about benefits of physical activity and weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory parameters | Ventilatory monitoring at night. Oxygen saturation continuously measured by a pulse oximeter. The following parameters are analysed:
| Baseline, immediate post-treatment, 18-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime sleepiness | Epworths sleepiness scale | Baseline, immediate post-treatment, 18-month follow-up |
| Attention and concentration |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernilla Åsenlöf, Professor | Department of Neuroscience, Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University and University Hospital | Uppsala | 751 24 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32024584 | Derived | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| CPAP | Device | CPAP-treatment as usual (during nights) |
|
| Baseline, immediate post-treatment, 18-month follow-up |
| Health-related quality of life | SF-36 | Baseline, immediate post-treatment, 18-month follow-up |
| Patients' priorities of daily activities and participation | The Patient Goal Priority Questionnaire | Baseline, immediate post-treatment, 18-month follow-up |
| Physical activity |
| Baseline, immediate post-treatment, 18-month follow-up |
| Functional physical capacity | 6 minutes walking distance | Baseline, immediate post-treatment, 18-month follow-up |
| Eating behaviour | Dutch eating behaviour questionnaire | Baseline, immediate post-treatment, 18-month follow-up |
| Self-efficacy and readiness to change behaviour |
| Baseline, mid-treatment, immediate post-treatment, 18-month follow-up |
| Anthropometrics |
| Baseline, immediate post-treatment, 18-month follow-up |
| Depression | MADRS Depression scale | Baseline, immediate post-treatment, 18-month follow-up |
| Fear of movement | Selected items from the Tampa Scale of Kinesiophobia | Baseline, mid-treatment, immediate post-treatment, 18-month follow-up |
| Blood sample |
| Baseline, immediate post-treatment, 18-month follow-up |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001522 | Behavior, Animal |