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OpenTrials
Completed

NCT Number: NCT03202602

Benefits of Telemedicine in CPAP Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard care

Other

Office visits and monitoring of CPAP treatment at each visit.

Primary outcomes

  1. CPAP adherence

    Time frame: 6 months

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

Secondary outcomes

  1. Patient satisfaction regarding CPAP treatment and contact with clinic

    Time frame: 6 months

    Patient satisfaction regarding CPAP treatment and contact with clinic. Assessed via questionnaire.

  2. Number of visits/contacts.

    Time frame: 6 months

    Number of visits/contacts. Assessed via hospital computer records.

  3. Duration of visits/contacts.

    Time frame: 6 months

    Time duration of visits/contacs. Assessed via hospital computer records.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

The Benefits of Telemedicine in CPAP Treatment of Obstructive Sleep Apnea Syndrome (OSAS)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2017
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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