MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System

Sleep Apnea Syndrome Clinical Trial

— MyOSA  

Official title:

MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116958
• Other study ID #: SEPAR 2016
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to improve CPAP treatment compliance of Obstructive Sleep Apnea Syndrome using an integrated telemedicine platform (MyOSA system)

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 evaluate the effect of adding a telemedicine approach to traditional follow up on CPAP treatment compliance, patients' satisfaction and follow-up costs.

Telemedicine will be provided by an integrated platform composed by a web site (https://www.myosa.net/menu/login.aspx) and a smartphone application.

Methods:

Design: Prospective randomised clinical study. Follow up: 6 months. Participants: 60 patients diagnosed as OSA at St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment.

Randomization: Patients will be randomized into two groups differing in CPAP treatment management (standard care vs. telemedicine). Patients of both groups will be visited in Sleep Unit at 3st and 6th month after starting CPAP treatment. The CPAP machine of both groups will be provided with a modem sending daily information about CPAP treatment compliance and adherence to MyOSA web site (this kind of information will only be actively used during the follow-up in the telemedicine group).

Intervention:

Group 1- Telemedicine Patients will be fitted with a mask , given a CPAP, and instructed on how to use the device. An intelligent software specifically developed for this project will be integrated in the web site. Using patients' baseline data (sociodemographic characteristics, presence of comorbidities, quality of life, sleepiness, pharmacologic treatment, toxic habits), the software will be capable to provide an initial prediction of the expected CPAP compliance at 6 months. Then, the real data about patients' treatment compliance sent on daily base by the CPAP machine will train the software improving the level of confidence of the prediction. Based on the prediction of compliance at six months, the software will provide specific and personalized interventions to modify or maintain this prediction. Interventions will be administered to the patients through a smartphone application connected to the web site and specifically developed for this study (MyOSA-App). Using the mobile-app patients will receive information about their own CPAP compliance and advice on how to improve compliance. All patients will be visited at 3 and 6 months at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine.

Group 2- Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Each CPAP machine will be provided with a modem sending daily compliance and adherence information to MyOSA web site but no intervention based on these data is planned in this group. All patients will be visited at 1, 3 and 6 months 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…).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and Women over 18 years old

• Diagnosed as OSA and requiring CPAP treatment

• Good knowledge of the use of a smartphone

• 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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• CPAP + Standard care
CPAP device + Standard management at Sleep Unit. According to Spanish Respiratory Society guidelines during 6 months
• CPAP + Telemedicine
CPAP+ telemedicine approach. Patients followed up at Sleep Unit according to Spanish Respiratory Society guidelines during 6 months.

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Eurecat

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP compliance	Number of hours of use per day of CPAP according to the internal clock of the CPAP device	6 months
Secondary	CPAP adherence	Numbers of night with more than 4 hours of use	6 months
Secondary	Patients' perceived ease of use of the telemedicine system	Patients in the telemedicine group will be asked to grade the perceived ease of use of the telemedicine platform using a questionnaire	6 months
Secondary	Patients' perceived useful of the telemedicine system	Patients in the telemedicine group will be asked to grade the perceived useful of the telemedicine platform using a questionnaire	6 months
Secondary	Patients' follow-up satisfaction	Patients of both group will be asked to grade their satisfaction with the follow up care provided by the sleep unit using a questionnaire.	6 months
Secondary	Change from baseline in quality of life at 6 months	EuroQOL health questionnaire will be used.	at baseline and 6 months
Secondary	Change from baseline in daytime sleepiness at 6 months	Epworth sleepiness scale will be used.	at baseline and 6 months
Secondary	Abandons at 6 months	Number of patients lost at follow up at 6 months of CPAP therapy.	6 months
Secondary	Cost effectiveness at 6 months	Costs in each group (telemedicine cost, CPAP carrying charge, number of visits and calls) will be compared.	6 months
Secondary	Changes in treatment side effects		6 months
Secondary	Change in blood pressure at 6 months		at baseline and 6 months
Secondary	Change in body mass index (in kg/m^2) at 6 months		at baseline and 6 months
Secondary	Change from baseline in Visual analogue scale for quality of life at 6 months	Visual analogue scale for quality of life will be used	at baseline and 6 months
Secondary	Change in weight (in kg) at 6 months		at baseline and 6 months