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Clinical Trials/NCT01715194
NCT01715194
Completed
Not Applicable

Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study

Otto D. Schoch1 site in 1 country240 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea Syndrome
Sponsor
Otto D. Schoch
Enrollment
240
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Otto D. Schoch
Responsible Party
Sponsor Investigator
Principal Investigator

Otto D. Schoch

Sponsor investigator

Cantonal Hospital of St. Gallen

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

Outcomes

Primary Outcomes

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

Time Frame: at 6 months

Secondary Outcomes

  • 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)

Study Sites (1)

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