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Life-style Changes in Obstructive Sleep Apnea

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StatusFullført
Sponsorer
Uppsala University
Samarbeidspartnere
The Swedish Research Council
Uppsala County Council, Sweden

Nøkkelord

Abstrakt

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.

Beskrivelse

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.

Datoer

Sist bekreftet: 10/31/2017
Først sendt: 04/11/2010
Anslått påmelding sendt: 04/11/2010
Først lagt ut: 04/12/2010
Siste oppdatering sendt: 11/05/2017
Siste oppdatering lagt ut: 11/07/2017
Faktisk studiestartdato: 04/30/2010
Anslått primær ferdigstillelsesdato: 02/29/2012
Anslått sluttdato for studien: 08/31/2014

Tilstand eller sykdom

Sleep Apnea, Obstructive
Obesity

Intervensjon / behandling

Behavioral: Tailored behavioural treatment and CPAP

Device: CPAP-treatment

Fase

-

Armgrupper

VæpneIntervensjon / behandling
Experimental: Tailored behavioural treatment and CPAP
Tailored behavioural treatment targeting physical activity and eating habits.
Behavioral: Tailored behavioural treatment and CPAP
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.
Active Comparator: CPAP-treatment
CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.
Device: CPAP-treatment
CPAP-treatment as usual (during nights)

Kvalifikasjonskriterier

Alder Kvalifisert for studier 18 Years Til 18 Years
Kjønn som kan studeresAll
Godtar sunne frivilligeJa
Kriterier

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

Utfall

Primære utfallstiltak

1. Ventilatory parameters [Baseline, immediate post-treatment, 18-month follow-up]

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

Sekundære utfallstiltak

1. Daytime sleepiness [Baseline, immediate post-treatment, 18-month follow-up]

Epworths sleepiness scale

2. Attention and concentration [Baseline, immediate post-treatment, 18-month follow-up]

COWAT Repetition of figures from WAIS

3. Health-related quality of life [Baseline, immediate post-treatment, 18-month follow-up]

SF-36

4. Patients' priorities of daily activities and participation [Baseline, immediate post-treatment, 18-month follow-up]

The Patient Goal Priority Questionnaire

5. Physical activity [Baseline, immediate post-treatment, 18-month follow-up]

Sensewear armband Physical activity diary

6. Functional physical capacity [Baseline, immediate post-treatment, 18-month follow-up]

6 minutes walking distance

7. Eating behaviour [Baseline, immediate post-treatment, 18-month follow-up]

Dutch eating behaviour questionnaire

8. Self-efficacy and readiness to change behaviour [Baseline, mid-treatment, immediate post-treatment, 18-month follow-up]

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

9. Anthropometrics [Baseline, immediate post-treatment, 18-month follow-up]

BMI Waist measurement Neck circumference

10. Depression [Baseline, immediate post-treatment, 18-month follow-up]

MADRS Depression scale

11. Fear of movement [Baseline, mid-treatment, immediate post-treatment, 18-month follow-up]

Selected items from the Tampa Scale of Kinesiophobia

12. Blood sample [Baseline, immediate post-treatment, 18-month follow-up]

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

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