Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS

Obstructive Sleep Apnea Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715194
• Other study ID #: EKSG 12/076
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: July 25, 2016
• Start date: December 2012
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• Telemedicine intervention
Patients undergoing telemedicine intervention

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen	St. Gallen	CH

Sponsors (1)

Lead Sponsor	Collaborator
Otto D. Schoch

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		at 6 months	No
Other	Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP)		at 6 months	No
Other	Proportion of CPAP users (defined as =1h of CPAP use per night within the last week) at 1 month		at 1 month	No
Other	Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1)		at 1 month	No
Other	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		at 1 month	No
Other	Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP)		at 1 month	No
Other	Mask leakage at 1 and 6 months		at 1 and 6 months	No
Other	Adverse effects on CPAP 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.	at 1 and 6 months	No
Other	Patient satisfaction (measured with a specifically designed short questionnaire and on a visual analogue scale (VAS)) at 1 and 6 months		at 1 and 6 months	No
Other	Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis.		at 6 months	No
Other	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".		at 1 and 6 months	No
Primary	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	No
Secondary	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	No