Benefits of Telemedicine in CPAP Treatment

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Standard care; Other: Telemonitoring of CPAP treatment

• Registration Number: NCT03202602
• Lead Sponsor: Uppsala University

Brief Summary

Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving a good treatment effect, and early intervention if treatment problems emerge is important for achieving good adherence, information on patient compliance is usually based on assessment of the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could therefore be an option allowing for adequate support and quick response if a patient has problems with the treatment. In addition, improving early experiences of CPAP, identifying patients in need of more intensive support could potentially improve adherence but also reduced cost of care, and increased patient satisfaction.

The proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients randomized to afterwards receiving telemonitoring in combination with telephone calls, and 100 patients randomized to receiving usual office visits. All patients will in addition answer questionnaires on sleep and health, quality of life, and patient satisfaction after the first CPAP information visit and then again after 6 months of treatment. At time of follow-up all patients will also answer questionnaires on side effects of CPAP. Health economic variables will also be measured throughout the testing period.

The study will provide valuable information regarding benefits of telemonitoring in clinical work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may be an important part of increasing adherence among patients but also in the development of a more cost-effective care as it can provide clinics with increased treatment capacity and follow-up of both new and established patients. It would further improve the care for these patients who often have a lifelong treatment, which aims to reduce the risk of developing cardiovascular disease or premature death.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-08-15
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Patients diagnosed with OSA and scheduled to receive CPAP treatment

Exclusion Criteria

• Patients not understandning Swedish
• Patients not eligible for CPAP start within a group session.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Patients randomized to receive usual office visits after CPAP start.
Telemedicine	Telemonitoring of CPAP treatment	Patients randomized to receive telemonitoring in combination with telephone calls after CPAP start.

Primary Outcome Measures

Name	Time	Method
CPAP adherence	6 months	Time of CPAP use at follow-up. Assesed from count in CPAP machine.

Secondary Outcome Measures

Name	Time	Method
Duration of visits/contacts.	6 months	Time duration of visits/contacs. Assessed via hospital computer records.
Patient satisfaction regarding CPAP treatment and contact with clinic	6 months	Patient satisfaction regarding CPAP treatment and contact with clinic. Assessed via questionnaire.
Number of visits/contacts.	6 months	Number of visits/contacts. Assessed via hospital computer records.

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden