Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Otto D. Schoch, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01715194
First received: October 10, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Syndrome
Device: Telemedicine intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
  • Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1) [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
  • Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP) [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
  • Mask leakage at 1 and 6 months [ Time Frame: at 1 and 6 months ] [ Designated as safety issue: No ]
  • Adverse effects on CPAP at 1 and 6 months [ Time Frame: at 1 and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 1 and 6 months ] [ Designated as safety issue: No ]
  • Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • 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". [ Time Frame: at 1 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Device: Telemedicine intervention
Other Name: ResMed Telemedicine S9 Wireless-Modul
No Intervention: Control (without telemedicine)
In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715194

Contacts
Contact: Otto D Schoch, MD 0041 71 494 2634 otto.schoch@kssg.ch
Contact: Florent Baty, PhD 0041 71 494 2809 florent.baty@kssg.ch

Locations
Switzerland
Cantonal Hospital St. Gallen Not yet recruiting
St. Gallen, CH, Switzerland, 9007
Contact: Otto D Schoch, MD    0041 71 494 2634    otto.schoch@kssg.ch   
Principal Investigator: Otto D Schoch, MD         
Sponsors and Collaborators
Otto D. Schoch
Investigators
Study Director: Martin Brutsche, MD, PhD Cantonal Hospital St. Gallen
  More Information

Publications:
Responsible Party: Otto D. Schoch, Sponsor investigator, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01715194     History of Changes
Other Study ID Numbers: EKSG 12/076
Study First Received: October 10, 2012
Last Updated: October 24, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
OSAS
CPAP
Adherence
Telemedicine

Additional relevant MeSH terms:
Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014