Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.

NCT03792880 | Completed

• 1 other identifier: 4/2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea; Telemedicine; Compliance, Patient

Keywords

CPAP treatment; Self-management

Outcome Measures

Primary Outcomes (1)

• Patients with a good CPAP compliance

  Percentage of patients with a CPAP compliance ≥4 hours per day. The main objective is to assess if a self-management and telematic control program can increase CPAP compliance getting at least 90% of patients using CPAP ≥4 hours per day.

  Six months

Secondary Outcomes (21)

• CPAP compliance

  Six months

• Dropout

  Six months

• Side effects

  Six months

• Efficacy of the treatment according to the change in sleepiness

  Six months

• Efficacy of the treatment according to the change in the frequency of the snoring.

  Six months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Usual follow-up in Healthcare System for patients with obstructive sleep apnea and CPAP treatment

Behavioral: Habitual follow-up in Healthcare System

Intervention arm

EXPERIMENTAL

Usual follow-up in the Healthcare System for patients with obstructive sleep apnea and CPAP treatment and a telematic control and self-management program

Behavioral: Telematic control and self-management program; Behavioral: Habitual follow-up in Healthcare System

Interventions

Telematic control and self-management program BEHAVIORAL

During 6 months with CPAP treatment, patients must complete some questionnaires about the presence of refreshing sleep and side effects with the frequency established, using a computing application. Patients can download this application on their own smartphone but, if they prefer, they can be provided with a tablet during the study with this application installed. A set of variables will be collected using an automatic and wireless transmission from latest generation CPAP to control the CPAP compliance and tolerance. All data will be processed in a platform to generate alarms, which will be controled daily by a researcher, as well as solutions to the problems presented during the monitoring.

Intervention arm

Habitual follow-up in Healthcare System BEHAVIORAL

According to the SEPAR regulation, patients treated with CPAP should be evaluated by the pulmonologist one month after beginning treatment, every 3 months during the first year, every 6 months during the second year and annually from the third year.

Control arm; Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virgen del Puerto Hospital: lead

Study Sites (2)

Virgen del Puerto Hospital

Plasencia, Cáceres, 10600, Spain

Location

San Pedro de Alcántara

Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Compliance

Interventions

Self-Management; Delivery of Health Care

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• María Ángeles Sánchez Quiroga

  Virgen del Puerto Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: January 4, 2019
• Study Start: June 1, 2019
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

ES (2)