Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Compliance, Patient
- Obstructive Sleep Apnea
- Telemedicine
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized control trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 expe...
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).
Tracking Information
- NCT #
- NCT03792880
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: María Ángeles Sánchez Quiroga Virgen del Puerto Hospital