Life-style Changes in Obstructive Sleep Apnea
Nøkkelord
Abstrakt
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
Intervensjon / behandling
Behavioral: Tailored behavioural treatment and CPAP
Device: CPAP-treatment
Fase
Armgrupper
Væpne | Intervensjon / 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 studeres | All |
Godtar sunne frivillige | Ja |
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]
Sekundære utfallstiltak
1. Daytime sleepiness [Baseline, immediate post-treatment, 18-month follow-up]
2. Attention and concentration [Baseline, immediate post-treatment, 18-month follow-up]
3. Health-related quality of life [Baseline, immediate post-treatment, 18-month follow-up]
4. Patients' priorities of daily activities and participation [Baseline, immediate post-treatment, 18-month follow-up]
5. Physical activity [Baseline, immediate post-treatment, 18-month follow-up]
6. Functional physical capacity [Baseline, immediate post-treatment, 18-month follow-up]
7. Eating behaviour [Baseline, immediate post-treatment, 18-month follow-up]
8. Self-efficacy and readiness to change behaviour [Baseline, mid-treatment, immediate post-treatment, 18-month follow-up]
9. Anthropometrics [Baseline, immediate post-treatment, 18-month follow-up]
10. Depression [Baseline, immediate post-treatment, 18-month follow-up]
11. Fear of movement [Baseline, mid-treatment, immediate post-treatment, 18-month follow-up]
12. Blood sample [Baseline, immediate post-treatment, 18-month follow-up]