Clinical trial NCT01715194: Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS
Official title: Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: OSAS
CPAP
Adherence
Telemedicine
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: at 6 months
Secondary outcomes:
measure: 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)
timeFrame: at 6 months
Other outcomes:
measure: 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
timeFrame: at 6 months
measure: Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP)
timeFrame: at 6 months
measure: Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month
timeFrame: at 1 month
measure: Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1)
timeFrame: at 1 month
measure: 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
timeFrame: at 1 month
measure: Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP)
timeFrame: at 1 month
measure: Mask leakage at 1 and 6 months
timeFrame: at 1 and 6 months
measure: Adverse effects on CPAP at 1 and 6 months
timeFrame: at 1 and 6 months
measure: Patient satisfaction (measured with a specifically designed short questionnaire and on a visual analogue scale (VAS)) at 1 and 6 months
timeFrame: at 1 and 6 months
measure: Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis.
timeFrame: at 6 months
measure: 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".
timeFrame: at 1 and 6 months
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
state: CH
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Martin Brutsche, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
citation: Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. doi: 10.1089/tmj.2004.10.162.
citation: Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.
citation: Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.
citation: Kwiatkowska M, Ayas N. Can telemedicine improve CPAP adherence? Thorax. 2010 Dec;65(12):1035-6. doi: 10.1136/thx.2010.140897. Epub 2010 Oct 26. No abstract available.
citation: Schoch OD, Baty F, Boesch M, Benz G, Niedermann J, Brutsche MH. Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study. Ann Am Thorac Soc. 2019 Dec;16(12):1550-1557. doi: 10.1513/AnnalsATS.201901-013OC.