Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: Telemedicine intervention

• Registration Number: NCT01715194
• Lead Sponsor: Otto D. Schoch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-26
• Study Start: 2012-12
• Primary Completion: 2015-12
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine intervention	Telemedicine intervention	In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if 1. CPAP was used \<4h/ night for 2 consecutive night 2. the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, CH, Switzerland