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

Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517346
• Other study ID #: SEPAR2015
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: April 14, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Other:
• Standard follow-up
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
• Telemonitoring
Follow up by telemonitoring system during 3 months

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova-Santa María	Lleida

Sponsors (3)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Asociacio Lleidatana de Respiratori, ResMed

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline in quality of life at 3 months	EuroQOL health questionnaire and visual analogue scale will be used.	3 months	No
Secondary	Fast detection of the non-adherent patient with telemonitoring	We assume that telemonitoring could quickly detect non- adherent patients.	3 months	No
Secondary	Change in blood pressure at 3 months		3 months	No
Secondary	Change in body mass index at 3 months		3 months	No
Secondary	Abandons at 3 months	Number of patients lost at follow up at 3 months of CPAP therapy.	3 months	No
Secondary	Adverse events at 3 months		3 months	No
Secondary	Change from baseline in snoring at 3 months	Patients will be asked about the persistence of snoring	3 months	No
Secondary	Change from baseline in witnessed apneas at 3 months	Patients will be asked about the persistence of witnessed apneas	3 months	No
Secondary	Change from baseline in nocturia at 3 months	Patients will be asked about the presence of nocturia.	3 months	No
Secondary	Change from baseline in daytime sleepiness at 3 months	Epworth sleepiness scale will be used.	3 months	No
Secondary	Changes in nocturnal gasping at 3 months	Patients will be asked about the persistence of nocturnal gasping	3 months	No
Secondary	Changes in sleep fragmentation at 3 months	Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia	3 months	No
Secondary	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	No