Clinical trial NCT03792880: Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.
Official title: Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea-hypopnea Syndrome, CPAP Treatment and Forecast of Poor Compliance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Telemedicine
Compliance, Patient
Keywords: CPAP treatment
Self-management
Lead sponsor: Virgen del Puerto Hospital
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: This clinical trial compares the usual follow-up to a program of telematic control and self-management in a group of patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS), few symptoms and treated with continuous positive airway pressure (CPAP). The objective of the intervention is to achieve a CPAP compliance of ≥4 hours per day in at least 90% of the subjects.

Detailed description: Low CPAP compliance in OSAHS could mean that its possible cardiovascular benefits are not achieved. Telemedicine can be an effective tool to increase CPAP compliance with low cost.

The researchers propose to carry out a randomized study about patients with severe OSAHS and few symptoms, who are expected to have low CPAP compliance.

The main objective is to evaluate if a telematic control and self-management program can increase the compliance with CPAP treatment compared to conventional follow-up, getting at least 90% of patients to use CPAP ≥ 4 hours per day.

Sixty patients from the Pneumology departments of two hospitals, diagnosed with severe OSAHS and with few symptoms (Epworth Sleepiness Scale ≤10) will be randomized to two follow-up groups, telematic and conventional, for 6 months. Patients in the intervention group (telematic monitoring) will collect variables related to symptoms of sleep apnea and side effects of CPAP treatment, using their own smartphone or a tablet provided during the study if they prefer. Other variables as the hours per day of CPAP use, leaks and residual apnea-hypopnea index (AHI) will be transmitted daily and automatically from latest generation CPAP. All information will be processed and each variable will generate alarms and instructions for each patient, allowing the self-management and an early solution of the possible problems related to the treatment. Alarms may also be generated in the database if the professional intervention is necessary.

In addition, before starting CPAP treatment and after six months of treatment, patients will be monitored during a week with a watch-like device. Variables related to circadian rhythm will be collected and analyzed to know the effect of CPAP treatment in both groups (control and intervention groups).

Eligibility criteria: Inclusion Criteria:

* Patients with a recent diagnostic of OSAHS with AHI≥ 30 and indication of CPAP.
* Age≥ 18 years
* Few symptoms, so that, without hypersomnolence (Epworth sleepiness scale ≤ 10)
* Absence of clinic suspect or confirmation of other sleep pathology
* With interest in the use of new technologies

Exclusion Criteria:

* Nasal obstruction that prevents the use of CPAP
* Psycho-physical inability to complete questionnaires and carry out the program
* Patients undergoing uvulopalatopharyngoplasty
* Cheyne-Stoke syndrome
* Pregnancy
* Absence of informed consent
* Shift work in the last 3 months and transmeridian trips in the last month.

Primary outcomes:
measure: Patients with a good CPAP compliance
timeFrame: Six months
Secondary outcomes:
measure: CPAP compliance
timeFrame: Six months
measure: Dropout
timeFrame: Six months
measure: Side effects
timeFrame: Six months
measure: Efficacy of the treatment according to the change in sleepiness
timeFrame: Six months
measure: Efficacy of the treatment according to the change in the frequency of the snoring.
timeFrame: Six months
measure: Efficacy of the treatment according to the change in the frequency of the witnessed apneas
timeFrame: Six months
measure: Efficacy of the treatment according to the change in the frequency of the refreshing sleep
timeFrame: Six months
measure: Presence of air leak and residual AHI
timeFrame: Six months
measure: Change of quality of life using the change in the EuroQol-5 dimensions-3 levels questionnaire.
timeFrame: Six months
measure: Effect of the treatment in the quality of sleep using the change in the rhythm of the distal skin temperature.
timeFrame: Six months
measure: Effect of the treatment in the quality of sleep using the change in the rhythm of activity.
timeFrame: Six months
measure: Effect of the treatment in the quality of sleep using the change in the rhythm of exposure to light
timeFrame: Six months
measure: Effect of the treatment in the quality of sleep using the change in the result of an integrated analysis of the distal skin temperature, activity and position records.
timeFrame: Six months
measure: Effect of the presence of a couple on the treatment efficacy.
timeFrame: Six months
measure: Effect of the age on the treatment efficacy
timeFrame: Six months
measure: Effect of the gender on the treatment efficacy
timeFrame: Six months
measure: Effect of the CPAP pressure on the treatment efficacy
timeFrame: Six months
measure: Effect of the type of mask on the treatment efficacy
timeFrame: Six months
measure: Effect of the use of humidifier on the treatment efficacy
timeFrame: Six months
measure: Effect of the presence of side effects on the treatment efficacy
timeFrame: Six months
measure: Cost-effectiveness analysis
timeFrame: Six months
Other outcomes:
Locations:
city: Plasencia
country: Spain
facility: Virgen del Puerto Hospital
state: Cáceres
city: Cáceres
country: Spain
facility: San Pedro de Alcántara
Study officials:
affiliation: Virgen del Puerto Hospital
name: María Ángeles Sánchez Quiroga
role: PRINCIPAL_INVESTIGATOR
References: