Obstructive Sleep Apnea Syndrome
Conditions
Keywords
OSAS, CPAP, Adherence, Telemedicine
Brief summary
We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy. The primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.
Interventions
Patients undergoing telemedicine intervention
Sponsors
Otto D. Schoch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of \>5/h in polysomnography (PSG) consenting to start longterm CPAP treatment.
Exclusion criteria
* Age \<18 years * Unable to communicate in German, English, French or Italian * Alcohol consumption \> 4 units \>4 times a week * Acute manifestation of psychiatric diseases * Life expectancy of \< 6 months for any reason * Surgical obesity treatment planned within the next 6 months * Predominantly Central sleep apnea and cheyne stokes respiration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1) | at 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP) | at 6 months | — |
| Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month | at 1 month | — |
| Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1) | at 1 month | — |
| Proportion of efficient CPAP users (defined as ≥4h of CPAP use per night within the last week including nights of no-use of CPAP) at 1 month | at 1 month | — |
| Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis. | at 6 months | — |
| Mask leakage at 1 and 6 months | at 1 and 6 months | — |
| Adverse effects on CPAP at 1 and 6 months | at 1 and 6 months | The proportion of patients with insomnia/dyssomnia due to CPAP, skin problems due to the mask, oronasal dryness or other treatment related complaints is assessed. |
| Patient satisfaction (measured with a specifically designed short questionnaire and on a visual analogue scale (VAS)) at 1 and 6 months | at 1 and 6 months | — |
| Cardiovascular risk factors in serum (e.g. cholesterol, C-peptid, ...), blood pressure and night time assessment of sleep quality with the novel assessment tool SOMNOcheck micro. | at 1 and 6 months | — |
| Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP) | at 1 month | — |
| Proportion of nights with efficient CPAP use (defined as ≥4h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months | at 6 months | — |
Countries
Switzerland
Outcome results
None listed