Obstructive Sleep ApneaTELESASNCT03792880
Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.
A study testing Habitual follow-up in Healthcare System in people with Obstructive Sleep Apnea and Telemedicine, run by Virgen del Puerto Hospital at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Telemedicine, Compliance, Patient
- What is being tested?
- Habitual follow-up in Healthcare System
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2019to 28 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
San Pedro de Alcántara
Cáceres, 10003
Virgen del Puerto Hospital
Plasencia, Cáceres, 10600
About this study
Official title: Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea-hypopnea Syndrome, CPAP Treatment and Forecast of Poor Compliance.
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.
Read the 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).
- Conditions
- Obstructive Sleep Apnea, Telemedicine, Compliance, Patient
- Being tested
- Telematic control and self-management program, Habitual follow-up in Healthcare System
- Keywords
- CPAP treatment, Self-management
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic control and self-management programBehavioural
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.
Habitual follow-up in Healthcare SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Usual follow-up in Healthcare System for patients with obstructive sleep apnea and CPAP treatment Receives: 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 Receives: Behavioral: Telematic control and self-management program; Behavioral: Habitual follow-up in Healthcare System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (21)
CPAP compliance
To compare CPAP compliance between both arms using the average compliance (hours of use per day) as secondary variable.
Measured: Six months
Dropout
To compare the dropout percentage between both arms
Measured: Six months
Side effects
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.
Measured: Six months
Efficacy of the treatment according to the change in sleepiness
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.
Measured: Six months
Efficacy of the treatment according to the change in the frequency of the snoring.
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
Measured: Six months
Efficacy of the treatment according to the change in the frequency of the witnessed apneas
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
Measured: Six months
Efficacy of the treatment according to the change in the frequency of the refreshing sleep
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
Measured: Six months
Presence of air leak and residual AHI
To compare the intensity of the air leak and residual AHI measured by the CPAP device between both arms.
Measured: Six months
Change of quality of life using the change in the EuroQol-5 dimensions-3 levels questionnaire.
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.
Measured: Six months
Effect of the treatment in the quality of sleep using the change in the rhythm of the distal skin temperature.
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.
Measured: Six months
Effect of the treatment in the quality of sleep using the change in the rhythm of activity.
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.
Measured: Six months
Effect of the treatment in the quality of sleep using the change in the rhythm of exposure to light
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.
Measured: Six months
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.
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.
Measured: Six months
Effect of the presence of a couple on the treatment efficacy.
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.
Measured: Six months
Effect of the age on the treatment efficacy
To analyze the influence of the patients' age on the percentage of patients with a CPAP compliance ≥4 hours per day in both arms.
Measured: Six months
Effect of the gender on the treatment efficacy
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.
Measured: Six months
Effect of the CPAP pressure on the treatment efficacy
To analyze the effect of the CPAP pressure on the percentage of patients with a CPAP compliance ≥4 hours per day in both arms.
Measured: Six months
Effect of the type of mask on the treatment efficacy
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.
Measured: Six months
Effect of the use of humidifier on the treatment efficacy
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.
Measured: Six months
Effect of the presence of side effects on the treatment efficacy
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.
Measured: Six months
Cost-effectiveness analysis
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).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jun 2019
- Primary completion28 Dec 2020
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virgen del Puerto Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Ángeles Sánchez Quiroga, Principal investigator, Virgen del Puerto Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792880
- Sponsor's protocol ID
- 4/2016
- Acronym
- TELESAS
- Status last verified
- Apr 2022
- First submitted
- 12 Oct 2018
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea-hypopnea Syndrome, CPAP Treatment and Forecast of Poor Compliance.
- ClinicalTrials.gov ID
- NCT03792880
- Acronym / sponsor ID
- TELESAS / 4/2016
- Conditions
- Obstructive Sleep Apnea, Telemedicine, Compliance, Patient
- Keywords
- CPAP treatment, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virgen del Puerto HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Behavioral: Habitual follow-up in Healthcare SystemUsual follow-up in Healthcare System for patients with obstructive sleep apnea and CPAP treatment |
| Intervention arm | Experimental | Behavioral: Telematic control and self-management program, Behavioral: Habitual follow-up in Healthcare SystemUsual follow-up in the Healthcare System for patients with obstructive sleep apnea and CPAP treatment and a telematic control and self-management program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telematic control and self-management programDuring 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. | Behavioural | Intervention arm |
| Habitual follow-up in Healthcare SystemAccording 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. | Behavioural | Control arm, Intervention arm |
Primary outcome
Patients with a good CPAP compliance
Time frame: 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.
21 secondary outcomes
CPAP compliance
Time frame: Six months
Dropout
Time frame: Six months
Side effects
Time frame: Six months
Efficacy of the treatment according to the change in sleepiness
Time frame: Six months
Efficacy of the treatment according to the change in the frequency of the snoring.
Time frame: Six months
Efficacy of the treatment according to the change in the frequency of the witnessed apneas
Time frame: Six months
Efficacy of the treatment according to the change in the frequency of the refreshing sleep
Time frame: Six months
Presence of air leak and residual AHI
Time frame: Six months
Change of quality of life using the change in the EuroQol-5 dimensions-3 levels questionnaire.
Time frame: Six months
Effect of the treatment in the quality of sleep using the change in the rhythm of the distal skin temperature.
Time frame: Six months
Effect of the treatment in the quality of sleep using the change in the rhythm of activity.
Time frame: Six months
Effect of the treatment in the quality of sleep using the change in the rhythm of exposure to light
Time frame: Six months
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.
Time frame: Six months
Effect of the presence of a couple on the treatment efficacy.
Time frame: Six months
Effect of the age on the treatment efficacy
Time frame: Six months
Effect of the gender on the treatment efficacy
Time frame: Six months
Effect of the CPAP pressure on the treatment efficacy
Time frame: Six months
Effect of the type of mask on the treatment efficacy
Time frame: Six months
Effect of the use of humidifier on the treatment efficacy
Time frame: Six months
Effect of the presence of side effects on the treatment efficacy
Time frame: Six months
Cost-effectiveness analysis
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Ángeles Sánchez Quiroga principal investigator
Virgen del Puerto Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual follow-up in Healthcare System in people with Obstructive Sleep Apnea and Telemedicine, run by Virgen del Puerto Hospital at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with a good CPAP compliance (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.