Cloud Based Follow up of CPAP Treatment

NCT ID: NCT03446560

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-23

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.

Conditions

Sleep Apnea Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP, conventional follow up

Follow up of patients after initiation of treatment according to clinical routine at the study site.

Group Type: ACTIVE_COMPARATOR

CPAP, conventional follow up

Intervention Type: DEVICE

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.

CPAP, telemedicine based follow up

Follow up of patients after initiation of treatment according to a telemedicine based routine.

Group Type: ACTIVE_COMPARATOR

CPAP, telemedicine based follow up

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Borås Lasarett

OTHER

Sponsor Role: collaborator

Skaraborgs Hospital

UNKNOWN

Sponsor Role: collaborator

NU-Hospital Organization, Sweden

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ludger Grote

MD, Senior Consultant, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ludger Grote

Role: PRINCIPAL_INVESTIGATOR

Respiratory Medicine, Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital, Sleep Disorders Center

Gothenburg, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 37463309 (View on PubMed)

Other Identifiers

227161

Identifier Type: REGISTRY

Identifier Source: secondary_id

VGFOUREG-663941

Identifier Type: -

Identifier Source: org_study_id