Clinical trial NCT02517346: Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
Official title: Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: CPAP compliance
Telemonitoring
Standard management
Cost effectiveness
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: ResMed
name: Asociacio Lleidatana de Respiratori
First posted: 2015-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: CPAP adherence at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Patients' satisfaction at 3 months
timeFrame: 3 months
measure: Cost effectiveness at 3 months
timeFrame: 3 months
measure: Change from baseline in quality of life at 3 months
timeFrame: 3 months
measure: Fast detection of the non-adherent patient with telemonitoring
timeFrame: 3 months
measure: Change in blood pressure at 3 months
timeFrame: 3 months
measure: Change in body mass index at 3 months
timeFrame: 3 months
measure: Abandons at 3 months
timeFrame: 3 months
measure: Adverse events at 3 months
timeFrame: 3 months
measure: Change from baseline in snoring at 3 months
timeFrame: 3 months
measure: Change from baseline in witnessed apneas at 3 months
timeFrame: 3 months
measure: Change from baseline in nocturia at 3 months
timeFrame: 3 months
measure: Change from baseline in daytime sleepiness at 3 months
timeFrame: 3 months
measure: Changes in nocturnal gasping at 3 months
timeFrame: 3 months
measure: Changes in sleep fragmentation at 3 months
timeFrame: 3 months
measure: Presence of symptoms of restlees leg syndrome at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova-Santa María
Study officials:
affiliation: Hospital Arnau de Vilanova. IRB Lleida. CIBERes
name: Ferran Barbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.