Clinical trial NCT03202602: Benefits of Telemedicine in CPAP Treatment
Official title: The Benefits of Telemedicine in CPAP Treatment of Obstructive Sleep Apnea Syndrome (OSAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Continuous positive airway pressure
Telemoedicine
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed obstructive sleep apnea syndrome (OSAS) scheduled to receive continuous positive airway pressure (CPAP).

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.


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.

Primary outcomes:
measure: CPAP adherence
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction regarding CPAP treatment and contact with clinic
timeFrame: 6 months
measure: Number of visits/contacts.
timeFrame: 6 months
measure: Duration of visits/contacts.
timeFrame: 6 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Jenny Theorell-Haglöw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.