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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Compliance, Patient; Telemedicine
• Interventions: Behavioral: Telematic control and self-management program; Behavioral: Habitual follow-up in Healthcare System

• Registration Number: NCT03792880
• Lead Sponsor: Virgen del Puerto Hospital

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).

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-04
• Study Start: 2019-06-01
• Primary Completion: 2020-12-28
• Study Completion: 2021-12-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Habitual follow-up in Healthcare System	Usual follow-up in the Healthcare System for patients with obstructive sleep apnea and CPAP treatment and a telematic control and self-management program
Control arm	Habitual follow-up in Healthcare System	Usual follow-up in Healthcare System for patients with obstructive sleep apnea and CPAP treatment
Intervention arm	Telematic control and self-management program	Usual follow-up in the Healthcare System for patients with obstructive sleep apnea and CPAP treatment and a telematic control and self-management program

Primary Outcome Measures

Name	Time	Method
Patients with a good CPAP compliance	Six months	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of the treatment according to the change in sleepiness	Six months	To compare the efficacy of the treatment using the change of the Epworth Sleepiness Scale score in both arms and between them.; This scale is a self-administered questionnaire and patients must rate their usual chances of dozing off or falling asleep while engaged in eight different daily activities. The possible answers for each situation and their scores are: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3= high chance of dozing. The Epworth Sleepiness Scale score is the sum of these 8 items scores and it can be interpreted as follows: 0-5 = lower normal daytime sleepiness; 6-10 = higher normal daytime sleepiness; 11-12 = mild excessive daytime sleepiness; 13-15 = moderate excessive daytime sleepiness; 16-24 = severe excessive daytime sleepiness.
Efficacy of the treatment according to the change in the frequency of the snoring.	Six months	To compare the efficacy of the treatment in both arms and between them using the change in the frequency of the snoring according to four levels: never, sometimes, frequently and always or almost always
Effect of the age on the treatment efficacy	Six months	To analyze the influence of the patients' age on the percentage of patients with a CPAP compliance ≥4 hours per day in both arms.
Effect of the gender on the treatment efficacy	Six months	To compare the efficacy of the treatment depending on the gender, comparing the percentage of patients with a CPAP compliance ≥4 hours per day between all men and all women, within each arm and between arms.
Dropout	Six months	To compare the dropout percentage between both arms
Side effects	Six months	To compare the control of side effects between both arms using the percentage of patients who have any of these effects during the follow-up.
Efficacy of the treatment according to the change in the frequency of the witnessed apneas	Six months	To compare the efficacy of the treatment in both arms and between them using the change in the frequency of the witnessed apneas according to four levels: never, sometimes, frequently and always or almost always
Effect of the treatment in the quality of sleep using the change in the rhythm of exposure to light	Six months	To compare the effect of the treatment in the quality of sleep using the change in the rhythm of exposure to light by ambulatory circadian monitoring including this variable. The investigators will compare the rhythm of this variable before and after CPAP treatment in both arms and the difference between them. For this propose, all randomized patients will carry a watch-like device for ambulatory circadian monitoring during one week before starting CPAP treatment and during the last week of the six months of follow-up and treatment with CPAP.
Effect of the use of humidifier on the treatment efficacy	Six months	To compare the efficacy of the treatment depending on the use of humidifier during the CPAP treatment, comparing the percentage of patients with a CPAP compliance ≥4 hours per day in the group of patients who use or not humidifier in both arms and between them.
Effect of the presence of side effects on the treatment efficacy	Six months	To compare the efficacy of the treatment depending on the presence of any side effect during the CPAP treatment, comparing the percentage of patients with a CPAP compliance ≥4 hours per day in the group of patients with and without any side effect in both arms and between them.
CPAP compliance	Six months	To compare CPAP compliance between both arms using the average compliance (hours of use per day) as secondary variable.
Efficacy of the treatment according to the change in the frequency of the refreshing sleep	Six months	To compare the efficacy of the treatment in both arms and between them using the change in the frequency of the refreshing sleep according to four levels: never, sometimes, frequently and always or almost always
Effect of the presence of a couple on the treatment efficacy.	Six months	To compare the efficacy of the treatment according to the presence or not of a couple, comparing the percentage of patients with CPAP compliance ≥4 hours per day between both groups of patients (all patients with and without couple), within each arm (control and intervention arm) and between arms.
Cost-effectiveness analysis	Six months	The researchers will perform a cost-effectiveness analysis using the average compliance as main variable of effectiveness, and the EuroQol-5 dimensions-3 levels descriptive system to calculate QALYs.; EuroQol-5 dimensions-3 levels descriptive system is a standardised measure of health status that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1 = no problems; 2 = some or moderate problems; 3 = extreme problems. The respondent have to indicate his/her health state according to the most appropiate statement in each dimension. The health state is defined by combining one level from each of the 5 dimensions (5 digit code) and then, this descriptive system is converted into a single index value facilitating comparisons and the calculation of quality-adjusted life years (QALYs).
Presence of air leak and residual AHI	Six months	To compare the intensity of the air leak and residual AHI measured by the CPAP device between both arms.
Effect of the treatment in the quality of sleep using the change in the rhythm of the distal skin temperature.	Six months	To compare the effect of the treatment in the quality of sleep using the change in the rhythm of distal skin temperature by ambulatory circadian monitoring including this variable. The investigators will compare the rhythm of this variable before and after CPAP treatment in both arms and the difference between them. For this propose, all randomized patients will carry a watch-like device for ambulatory circadian monitoring during one week before starting CPAP treatment and during the last week of the six months of follow-up and treatment with CPAP.
Effect of the treatment in the quality of sleep using the change in the rhythm of activity.	Six months	To compare the effect of the treatment in the quality of sleep using the change in the rhythm of activity by ambulatory circadian monitoring including this variable. The investigators will compare the rhythm of this variable before and after CPAP treatment in both arms and the difference between them. For this propose, all randomized patients will carry a watch-like device for ambulatory circadian monitoring during one week before starting CPAP treatment and during the last week of the six months of follow-up and treatment with CPAP.
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.	Six months	To compare the 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 obtained by ambulatory circadian monitoring including these variables. The researchers will compare this result before and after CPAP treatment in both arms and the difference between them. For this propose, all randomized patients will carry a watch-like device for ambulatory circadian monitoring during one week before starting CPAP treatment and during the last week of the six months of follow-up and treatment with CPAP.
Effect of the CPAP pressure on the treatment efficacy	Six months	To analyze the effect of the CPAP pressure on the percentage of patients with a CPAP compliance ≥4 hours per day in both arms.
Change of quality of life using the change in the EuroQol-5 dimensions-3 levels questionnaire.	Six months	To compare the change of quality of life before and after the follow-up in both arms and between them, using the change in the EuroQol-5 dimensions-3 levels questionnaire. This is a standardised measure of health status that comprises a descriptive system and a visual analogue scale. The first comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1 = no problems; 2 = some or moderate problems; 3 = extreme problems. The health state is defined by combining one level from each dimension (5 digit code). This descriptive system is converted into a single index value facilitating comparisons and the calculation of quality-adjusted life years (QALYs). The visual analogue scale records the respondent's self-rated health on a 20 centimeters vertical, visual analogue scale with endpoints labeled as: 100 = the best health you can imagine and 0. = the worst health you can imagine.
Effect of the type of mask on the treatment efficacy	Six months	To compare the efficacy of the treatment depending on the type of mask used during the CPAP treatment, comparing the percentage of patients with a CPAP compliance ≥4 hours per day in the group of patients who use nasal pillow, full face and nasal mask in both arms and between them.

Trial Locations

Locations (2)

Virgen del Puerto Hospital; 🇪🇸 Plasencia, Cáceres, Spain

San Pedro de Alcántara; 🇪🇸 Cáceres, Spain