Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

NCT ID: NCT02517346

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).

Detailed Description

Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units.

So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs.

Methods:

Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management .

Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…).

Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database.

Patients of both 2 groups will be finally visited at 3 months at sleep unit.

Conditions

Sleep Apnea Syndrome

Study Design

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

Study Groups

Standard follow up-Sleep Unit

Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit

Group Type: ACTIVE_COMPARATOR

Standard follow-up

Intervention Type: OTHER

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Telemonitoring

Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system

Group Type: EXPERIMENTAL

Telemonitoring

Intervention Type: OTHER

Follow up by telemonitoring system during 3 months

Interventions

Standard follow-up

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Intervention Type: OTHER

Telemonitoring

Follow up by telemonitoring system during 3 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and Women over 18 years old
• Diagnosed as OSA and requiring CPAP treatment
• Written informed consent form signed.

Exclusion Criteria

• Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)
• Severe heart failure
• Severe chronic pathology associated
• Psychiatric disorder
• Periodic leg movements
• Pregnancy
• Other dyssomnias or parasomnias
• Patients already treated with CPAP

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

Sponsors

ResMed

INDUSTRY

Sponsor Role: collaborator

Asociacio Lleidatana de Respiratori

UNKNOWN

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Ferran Barbe

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Barbe, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Locations

Hospital Arnau de Vilanova-Santa María

Lleida, Lleida, Spain

Countries

Spain

References

Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gomez S, Dalmases M, Sanchez-de-la-Torre M, Barbe F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2):1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb.

Reference Type: DERIVED

PMID: 28179438 (View on PubMed)

Other Identifiers

SEPAR2015

Identifier Type: -

Identifier Source: org_study_id