Clinical trial NCT03446560: Cloud Based Follow up of CPAP Treatment
Official title: Cloud Based Follow up of CPAP Treatment in Sleep Apnea Patients - a Multi Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: Compliance
Telemedicine
Patient related outcome measures
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Borås Lasarett
name: Skaraborgs Hospital
name: NU-Hospital Organization, Sweden
First posted: 2018-02-27
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label, multicenter, parallell group design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: CPAP treatment compliance at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Reduction of daytime sleepiness
timeFrame: 3 months
measure: Reduction of the degree of sleep apnea
timeFrame: 3 months
measure: Non Acceptance Rate of CPAP therapy
timeFrame: 3 months
measure: Health care utilization during follow up
timeFrame: 3 months
measure: Patient satisfaction regarding the follow up procedure
timeFrame: 3 months
Other outcomes:
measure: Degree of comorbid depression and anxiety symptoms
timeFrame: 3 months
measure: Degree of comorbid insomnia
timeFrame: 3 months
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Sleep Disorders Center
Study officials:
affiliation: Respiratory Medicine, Sahlgrenska University Hospital
name: Ludger Grote
role: PRINCIPAL_INVESTIGATOR
References: