Cloud Based Follow up of CPAP Treatment
2 other identifiers
interventional
403
1 country
1
Brief Summary
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based follow up procedure. Main endpoint parameter is CPAP treatment compliance at 3 months after start of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2019
CompletedJanuary 14, 2020
January 1, 2020
1.3 years
January 18, 2018
January 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CPAP treatment compliance at 3 months
Mean nightly use of CPAP treatment (h/night) according to the built in time counter of the CPAP device, between group difference
3 months
Secondary Outcomes (5)
Reduction of daytime sleepiness
3 months
Reduction of the degree of sleep apnea
3 months
Non Acceptance Rate of CPAP therapy
3 months
Health care utilization during follow up
3 months
Patient satisfaction regarding the follow up procedure
3 months
Other Outcomes (2)
Degree of comorbid depression and anxiety symptoms
3 months
Degree of comorbid insomnia
3 months
Study Arms (2)
CPAP, conventional follow up
ACTIVE COMPARATORFollow up of patients after initiation of treatment according to clinical routine at the study site.
CPAP, telemedicine based follow up
ACTIVE COMPARATORFollow up of patients after initiation of treatment according to a telemedicine based routine.
Interventions
Positive airway pressure to splint the airway and to prevent apneas during sleep. Follow up of patients after initiation of treatment according to clinical routine at the study site. Patients are informed to call or visit the sleep center in case of problems with the CPAP device. At 3 months a follow up visit is scheduled at the sleep center. CPAP compliance data will be downloaded and all patients fill in a number of questionaires related to the CPAP treatment effects on sleep apnea symptoms and health related quality of Life. Mask fitting will be tested.
Follow up of patients by means of a telemedicine solution for surveillance of CPAP treatment, Compliance with and efficacy of CPAP can be followed up by the sleep center personnel on a regular basis. Patients with low compliance and mask fitting problems will be contacted by phone. At the end of the 3 months period a visit at the sleep center will be scheduled only for patients with low compliance, low treatment efficacy, or high mask leakage. All patients will be asked to fill in a number of questionaires related to CPAP treatment effects on sleep apnea symptoms and health related quality of Life.
Eligibility Criteria
You may qualify if:
- Verified sleep apnea diagnosis according to ICSD II criteria
- Indication for CPAP treatment according to Swedish national guidelines
- Capacity to read and understand the Swedish language
- Willingness to test CPAP treatment
You may not qualify if:
- Instable concomitant disease requiring frequent hospitalization
- Alcohol and drug abuse
- Non-availability during the follow up during 3 months (e.g. frequent or long-term travelling)
- Hypoventilation syndrome with PCO2\>7kpa
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vastra Gotaland Regionlead
- Borås Lasarettcollaborator
- Skaraborgs Hospitalcollaborator
- NU-Hospital Organization, Swedencollaborator
Study Sites (1)
Sahlgrenska University Hospital, Sleep Disorders Center
Gothenburg, 41345, Sweden
Related Publications (1)
Fridriksson B, Berndtson M, Hamnered H, Faeder E, Zou D, Hedner J, Grote L. Beneficial Effects of Early Intervention Telemedicine-based Follow-Up in Sleep Apnea: A Randomized Controlled Multicenter Trial. Ann Am Thorac Soc. 2023 Oct;20(10):1499-1507. doi: 10.1513/AnnalsATS.202208-723OC.
PMID: 37463309DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ludger Grote
Respiratory Medicine, Sahlgrenska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Senior Consultant, Professor
Study Record Dates
First Submitted
January 18, 2018
First Posted
February 27, 2018
Study Start
January 1, 2018
Primary Completion
April 30, 2019
Study Completion
December 23, 2019
Last Updated
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share