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Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Telemonitoring via wireless internet-based system
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, CPAP treatment, telemedicine, nursing time, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemonitoring

Usual care

Arm Description

After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device

Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring

Outcomes

Primary Outcome Measures

Nursing time
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 Outcome Measures

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

Full Information

First Posted
April 26, 2021
Last Updated
April 29, 2021
Sponsor
University of Turku
Collaborators
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04868422
Brief Title
Telemonitoring of CPAP Therapy in Sleep Apnea Patients
Official Title
Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2012 (Actual)
Primary Completion Date
August 12, 2014 (Actual)
Study Completion Date
March 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
Collaborators
Turku University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, CPAP treatment, telemedicine, nursing time, patient satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring
Arm Type
Experimental
Arm Description
After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring
Intervention Type
Device
Intervention Name(s)
Telemonitoring via wireless internet-based system
Primary Outcome Measure Information:
Title
Nursing time
Description
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.
Time Frame
One year after the baseline
Secondary Outcome Measure Information:
Title
Hours of CPAP use
Description
Hours of CPAP use measured by the inbuilt counter of the CPAP device
Time Frame
One year after baseline
Other Pre-specified Outcome Measures:
Title
Residual apnea-hypopnea index (AHI)
Description
Maan AHI over 12 months according the CPAP-device
Time Frame
One year after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with diagnosed obstructive sleep apnea Exclusion Criteria: Not able to understand Finnish language Unable to co-operate
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

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Telemonitoring of CPAP Therapy in Sleep Apnea Patients

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