Telemonitoring of CPAP Therapy in Sleep Apnea Patients

NCT04868422 | Completed

• 2 other identifiers: T83/2012K53
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea; CPAP treatment; telemedicine; nursing time; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  One year after the baseline

Secondary Outcomes (1)

• Hours of CPAP use

  One year after baseline

Other Outcomes (1)

• Residual apnea-hypopnea index (AHI)

  One year after baseline

Study Arms (2)

Telemonitoring

EXPERIMENTAL

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

Device: Telemonitoring via wireless internet-based system

Usual care

NO INTERVENTION

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

Interventions

Telemonitoring via wireless internet-based system DEVICE

Telemonitoring

Eligibility Criteria

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

You may qualify if:

• Adult patients with diagnosed obstructive sleep apnea

You may not qualify if:

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

Sponsors & Collaborators

• University of Turku: lead
• Turku University Hospital: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Patient Satisfaction

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: August 14, 2012
• Primary Completion: August 12, 2014
• Study Completion: March 12, 2015
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

FI (1)