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OpenTrials
Completed

NCT Number: NCT01715194

Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital St. Gallen

Sankt Gallen, CH, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine intervention

Device

Patients undergoing telemedicine intervention

Other names: ResMed Telemedicine S9 Wireless-Modul

Primary outcomes

  1. 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

  1. 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

Other outcomes

  1. 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

  2. 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

  3. Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month

    Time frame: at 1 month

  4. 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

  5. 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

  6. 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

  7. Mask leakage at 1 and 6 months

    Time frame: at 1 and 6 months

  8. Adverse effects on CPAP at 1 and 6 months

    Time frame: 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.

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Otto D. Schoch

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2012
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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