Benefits of Telemedicine in CPAP Treatment

NCT03202602 | Completed

• 1 other identifier: TelemedCPAP
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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

Keywords

Obstructive sleep apnea; Continuous positive airway pressure; Telemoedicine

Outcome Measures

Primary Outcomes (1)

• CPAP adherence

  Time of CPAP use at follow-up. Assesed from count in CPAP machine.

  6 months

Secondary Outcomes (3)

• Patient satisfaction regarding CPAP treatment and contact with clinic

  6 months

• Number of visits/contacts.

  6 months

• Duration of visits/contacts.

  6 months

Study Arms (2)

Telemedicine

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

Other: Telemonitoring of CPAP treatment

Standard care

Patients randomized to receive usual office visits after CPAP start.

Other: Standard care

Interventions

Telemonitoring of CPAP treatment OTHER

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

Telemedicine

Standard care OTHER

Office visits and monitoring of CPAP treatment at each visit.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed obstructive sleep apnea syndrome (OSAS) scheduled to receive continuous positive airway pressure (CPAP).

You may qualify if:

• Patients diagnosed with OSA and scheduled to receive CPAP treatment

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

Related Publications (2)

• 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.

  PMID: 37337981 RESULT

• 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.

  PMID: 37323036 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jenny Theorell-Haglöw, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: June 28, 2017
• Study Start: August 15, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)