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OpenTrials
Completed

NCT Number: NCT04868422

Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Patient Satisfaction Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, 20521, Finland

About this study

Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was >4 h/day, mask leak <0.4 L/s, and AHI <5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with diagnosed obstructive sleep apnea

Exclusion criteria

  • Not able to understand Finnish language
  • Unable to co-operate

Treatment and study plan

Telemonitoring via wireless internet-based system

Device

Primary outcomes

  1. Nursing time

    Time frame: One year after the baseline

    Nursing time of the TM group was estimated as follows: patient education regarding ResTraxx™ Online system (2 min), online data check-ups (0.5 min), remote changes for pressure settings (1 min), telephone guidance (5 min for the end of monitoring, 10 min for each extra call), visit at the study nurse (30- 60 min depending on type of visit), updating the patient records (2 min), and no show visits, which led to organizing a new appointment (20min). The time estimations are based on the measurements of the first 20 telemonitored patients. Nursing time in the UC Group was estimated with the same time calculations as in the TM group presented above with the exception of ttelemonitoring time which was not applicable in the UC group.

Secondary outcomes

  1. Hours of CPAP use

    Time frame: One year after baseline

    Hours of CPAP use measured by the inbuilt counter of the CPAP device

Other outcomes

  1. Residual apnea-hypopnea index (AHI)

    Time frame: One year after baseline

    Maan AHI over 12 months according the CPAP-device

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Turku University Hospital

Registry information

Official study title

Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 3, 2021
Registry last updated
May 3, 2021

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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