NCT03446560

Cloud Based Follow up of CPAP Treatment

Cloud Based Follow up of CPAP Treatment in Sleep Apnea Patients - a Multi Center Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	CPAP, conventional follow up	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.
DEVICE	CPAP, telemedicine based follow up	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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-04-30
• Completion: 2019-12-23
• First posted: 2018-02-27
• Last updated: 2020-01-14

Locations

1 site across 1 country: Sweden