Benefits of Telemedicine in CPAP Treatment

NCT ID: NCT03202602

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-12-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Telemedicine

Patients randomized to receive telemonitoring in combination with telephone calls after CPAP start.

Telemonitoring of CPAP treatment

Intervention Type: OTHER

Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis.

Standard care

Patients randomized to receive usual office visits after CPAP start.

Standard care

Intervention Type: OTHER

Office visits and monitoring of CPAP treatment at each visit.

Interventions

Telemonitoring of CPAP treatment

Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis.

Intervention Type: OTHER

Standard care

Office visits and monitoring of CPAP treatment at each visit.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Jenny Theorell-Haglöw

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny Theorell-Haglöw, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University

Uppsala, , Sweden

Countries

Sweden

References

Ssegonja R, Ljunggren M, Sampaio F, Tegelmo T, Theorell-Haglow J. Economic evaluation of telemonitoring as a follow-up approach for patients with obstructive sleep apnea syndrome starting treatment with continuous positive airway pressure. J Sleep Res. 2024 May;33(3):e13968. doi: 10.1111/jsr.13968. Epub 2023 Jun 20.

Reference Type: RESULT

PMID: 37337981 (View on PubMed)

Delijaj F, Lindberg E, Johnsson L, Kristiansson P, Tegelmo T, Theorell-Haglow J. Effects of telemonitoring follow-up, side effects, and other factors on CPAP adherence. J Clin Sleep Med. 2023 Oct 1;19(10):1785-1795. doi: 10.5664/jcsm.10686.

Reference Type: RESULT

PMID: 37323036 (View on PubMed)

Other Identifiers

TelemedCPAP

Identifier Type: -

Identifier Source: org_study_id