Cloud Based Follow up of CPAP Treatment

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: CPAP, telemedicine based follow up; Device: CPAP, conventional follow up

• Registration Number: NCT03446560
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Background:

Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP, during sleep. CPAP startup and follow-up is performed at four sleep clinics in the West Swedish Region (SU / S, SÄS, SkaS, NÄL). Patient volumes are high, waiting times are long and long-term follow-up is inconsistent. A new technology that enables telemetric monitoring of CPAP therapy based on transfer of therapy data to a data cloud has been introduced. Healthcare personnel can identify patients with therapy problems.

Data from minor studies suggest several benefits of this telemedicine solution (increased therapeutic capacity, lower patient and community costs and a time benefit for the sleep medicine unit). Today, the sleep Clinical in the region use different procedures for monitoring CPAP treatment.

Scientific question:

Is telemedicine monitoring of CPAP treatment an adequate solution for follow up in all patients ? Is the additional cost of a telemedicine solution balanced by a better outcome after therapy?

Hypothesis:

Intensive telemedicine monitoring, especially at the start of CPAP therapy, leads to improved CPAP care at the participating sleep units.

Method:

The study randomizes 560 patients (moderate to severe sleep apnea) to different CPAP treatment follow up procedures: A) the current routine of the sleep clinic or B) the new telemedicine solution (1: 1 randomization). The main outcome parameter of the study is the mean CPAP use after 3 months of treatment. Secondary outcome parameters include the reduction of sleep apnea intensity, daytime sleepiness, and patient-related outcome measures (PROM).

Aim:

The aim of the study is to map the pros and cons of a telemedicine solution in CPAP therapy regarding treatment outcomes, patient quality of life and resource utilization at the sleep center.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-27
• Primary Completion: 2019-04-30
• Study Completion: 2019-12-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP, telemedicine based follow up	CPAP, telemedicine based follow up	Follow up of patients after initiation of treatment according to a telemedicine based routine.
CPAP, conventional follow up	CPAP, conventional follow up	Follow up of patients after initiation of treatment according to clinical routine at the study site.

Primary Outcome Measures

Name	Time	Method
CPAP treatment compliance at 3 months	3 months	Mean nightly use of CPAP treatment (h/night) according to the built in time counter of the CPAP device, between group difference

Secondary Outcome Measures

Name	Time	Method
Reduction of daytime sleepiness	3 months	Reduction of the score in the Epworth Sleepiness Scale Score (range 0-24, 0=no sleepiness, 24=very high sleepiness, summary score from 8 different questions about the probability of daytime sleepiness, each question can generate between 0=unlikely and 4=highly likely points), assessment at baseline and at follow up, between group difference
Reduction of the degree of sleep apnea	3 months	Between Group difference in the reduction of the Apnea Hypopnea Index (n/h) from baseline (no treatment) to follow up (with CPAP on)
Non Acceptance Rate of CPAP therapy	3 months	Proportion of patients refusing CPAP therapy, between group difference
Health care utilization during follow up	3 months	Time spent for follow up procedures by the Health care personel, between group difference
Patient satisfaction regarding the follow up procedure	3 months	Visual Analogue Scale (VAS) Rating of patient satisfaction with the two different follow up procedures, VAS scale has 0 to 100 Points where 0=very low satisfaction and 100= very high satisfaction, no subscales.

Trial Locations

Locations (1)

Sahlgrenska University Hospital, Sleep Disorders Center; 🇸🇪 Gothenburg, Sweden