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

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).

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndrome
• Intervention / Treatment: Other: Standard follow-up; Other: Telemonitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Hospital Arnau de Vilanova-Santa Maria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard follow up-Sleep Unit; Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit	Other: Standard follow-up; Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
Experimental: Telemonitoring; Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system	Other: Telemonitoring; Follow up by telemonitoring system during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP adherence at 3 months	Number of hours of use per day of CPAP according to the internal clock of the CPAP device	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' satisfaction at 3 months	Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale.	3 months
Cost effectiveness at 3 months	Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared.	3 months
Change from baseline in quality of life at 3 months	EuroQOL health questionnaire and visual analogue scale will be used.	3 months
Fast detection of the non-adherent patient with telemonitoring	We assume that telemonitoring could quickly detect non- adherent patients.	3 months
Change in blood pressure at 3 months		3 months
Change in body mass index at 3 months		3 months
Abandons at 3 months	Number of patients lost at follow up at 3 months of CPAP therapy.	3 months
Adverse events at 3 months		3 months
Change from baseline in snoring at 3 months	Patients will be asked about the persistence of snoring	3 months
Change from baseline in witnessed apneas at 3 months	Patients will be asked about the persistence of witnessed apneas	3 months
Change from baseline in nocturia at 3 months	Patients will be asked about the presence of nocturia.	3 months
Change from baseline in daytime sleepiness at 3 months	Epworth sleepiness scale will be used.	3 months
Changes in nocturnal gasping at 3 months	Patients will be asked about the persistence of nocturnal gasping	3 months
Changes in sleep fragmentation at 3 months	Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia	3 months
Presence of symptoms of restlees leg syndrome at 3 months	Patients will be asked about the presence of symptoms of restless leg syndrome	3 months

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Collaborators: ResMed; Asociacio Lleidatana de Respiratori

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Telemonitoring; Cost effectiveness; CPAP compliance; Standard management
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: SEPAR2015