The effect of telemonitoring on adherence to continuous positive airway pressure in sleep apnea hypopnea syndrome
| ISRCTN | ISRCTN12865936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12865936 |
| Secondary identifying numbers | CCER2016-01601 |
- Submission date
- 18/01/2017
- Registration date
- 26/01/2017
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Sleep apnea-hypopnea syndrome (SAHS) is a common condition that makes it difficult to breathe due to narrowing of the throat while sleeping. Some of the symptoms include trouble sleeping, snoring, and difficulty in breathing. SAHS can increase the risk of high blood pressure, heart attacks, diabetes and stroke. Continuous positive airway pressure (CPAP) treatment is one of the main treatments for SAHS. CPAP is a facemask connected to a pump that provides an airflow that stops the throat from closing while sleeping. This treatment is a key reason in improving health issues associated with SAHS. However, it is found that many people do not always use their CPAP machine as it can be uncomfortable and can cause headaches, runny nose, ear pain, and difficulty breathing through the nose. The CPAP can be changed to be more comfortable for the patient through follow up appointments and discussions with treatment staff. In order to help patients continue with their CPAP usage, multiple ways of following up with patients are can be used, such as telemonitoring (monitoring through the usage of technology to get in contact with treatment staff). The aim of this study is to assess whether telemonitoring-based CPAP follow-up can improve the amount of people who continue to use the CPAP compared to the standard face-to-face follow-up.
Who can participate?
Adults diagnosed with SAHS that are starting CPAP therapy.
What does the study involve?
Participants are allocated randomly to one of two groups. The first group has three face to face appointments with a respiratory therapist. During the first appointment the CPAP is set up. During the following two appointments the CPAP usage is monitored, the settings are checked and side effects are discussed. The telemonitoring group has only one face to face appointment with a respiratory therapist to set up the CPAP. The following two appointments are done remotely. The respiratory therapist is able to remotely access the CPAP to check the settings, monitor the usage and then will discuss how to manage side effects with the patients over the phone. All participants have follow up appointments with a pneumologist 3 and 12 months after beginning CPAP treatment.
What are the possible benefits and risks of participating?
Participants may benefit from being able to have their CPAP appointments done remotely as they will not have to travel to the respiratory center. There are no notable risks of taking part of the study
Where is the study run from?
1. Centre de Médecine du Sommeil et de l'Eveil (Switzerland)
2. Centre Médical de la Servette (Switzerland)
When is the study starting and how long is it expected to run for?
September 2016 to December 2018.
Who is funding the study?
Ligue Pulmonaire Genevoise (Switzerland)
Who is the main contact?
Olivier Contal
olivier.contal@hesav.ch
Contact information
Scientific
Av de Beaumont 21
Lausanne
1011
Switzerland
| Phone | +41 21 316 81 22 |
|---|---|
| olivier.contal@hesav.ch |
Study information
| Study design | Single-center prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | The effect of Telemonitoring on adherence at one year to Continuous Positive Airway Pressure in sleep apnea hypopnea syndrom: A randomised controlled trial |
| Study acronym | TeleCPAP |
| Study hypothesis | The aim of this study is to evaluate if telemonitoring follow-up enhances the adherence to CPAP treatment compared to standard care to face telemonitoring management. |
| Ethics approval(s) | Commission cantonale d’éthique de la recherche scientifique de Genève (CCER), 12/12/2016, ref: 2016-01601 |
| Condition | Sleep Apnea Hypopnea Syndrome |
| Intervention | Participants are referred to the trial through the diagnosis of sleep apnea-hypopnea syndrome (SAHS) and prescription for continuous positive airway pressure (CPAP) by a pneumologist. Participants will be allocated to groups through the usage of a randomisation program. Envelopes numbered from 1 to 120, prepared by independent member of our staff, allocate the participants to one of two groups: Standard group: Participants receive three face-to-face appointments in order to initiate and setting/monitoring of the CPAP with a respiratory therapist. The first appointment includes explanations about SAHS and CPAP, identification of the adequate interface, how to set the CPAP for titration with autoadjusting (APAP) and a band of pressure in accordance with pneumologist prescription, and will review symptoms of depression. The second appointment (1 or 2 weeks later) includes checking the CPAP objectives by downloading the memory card from the CPAP in order to evaluate how well the CPAP is working (reviewing leaks, adherence, AHI), discussing management of the side effects of the CPAP and fixating the treatment pressure at the 95th percentile pressure during the titration phrase. The third appointment (1 or 2 weeks after the second appointment) includes checking the CPAP objectives by downloading the memory card from the CPAP in order to evaluate how well the CPAP is working (reviewing leaks, adherence, AHI) and discussing management of the side effects of the CPAP. Following the three respiratory appointments, participants have two follow up appointments with the pneumologist 3 and 12 months after beginning the CPAP treatment. This includes a clinical evaluation, checking the CPAP objectives by downloading the memory card, reviewing depression symptoms and oxymetry. Telemonitoring group: Participants only receive 1 face-to-face appointment for the initiation of the CPAP and then the monitoring and the settings are proceeded through the usage of telemonitoring. The first appointment includes explanations about SAHS and CPAP, identification of the adequate interface, how to set the CPAP for titration with autoadjusting (APAP) and a band of pressure in accordance with pneumologist prescription, and will review symptoms of depression. The second appointment with the respiratory therapist takes place over the phone. The respiratory therapist receives the information regarding CPAP objectives remotely through the airview program and they review this with the participant. They also review the management of side effects and they remotely fix the treatment pressure at the 95th percentile pressure during titration phase by the airview program. The third appointment again takes place over the phone and the respiratory therapist reviews the CPAP objectives and discusses the management of side effects. Following the three respiratory appointments, participants have two follow up appointments with the pneumologist 3 and 12 months after beginning the CPAP treatment. This includes a clinical evaluation, checking the CPAP objectives by downloading the memory card, reviewing depression symptoms and oxymetry. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Mean CPAP use (hours/day) is measured by reviewing the downloaded data of the CPAP machine at 3 months and 12 months. |
| Secondary outcome measures | 1. Percentage of adherent patients (>4h/day) is measured by reviewing the downloaded data of the CPAP machine at 3 months and 12 months 2. Percentage of treatment discontinuation is measured by reviewing the downloaded data of the CPAP machine at 3 months and 12 months 3. Time of nursing work in minutes measured using a chronometer. The time of nursing work is recorded at the end of each appointment on a specific sheet |
| Overall study start date | 01/09/2016 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Participant inclusion criteria | 1. Diagnosis of Sleep apnea hypopnea syndrome 2. The Apnea Hypopnea Index (AHI) recorded as greater than 15 per hour 3. Patient starting CPAP therapy 4. Over the age of 18 |
| Participant exclusion criteria | 1. Previously treated for SAHS 2. Pregnant or nursing |
| Recruitment start date | 16/01/2017 |
| Recruitment end date | 30/08/2017 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Geneva
1201
Switzerland
Geneva
1203
Switzerland
Sponsor information
Other
Av. Cardinal-Mermillod 42-44
Carouge
1227
Switzerland
| Phone | +41 22 309 09 90 |
|---|---|
| ligue@lpg.ch | |
"ROR" |
https://ror.org/02ra2yn55 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | Data will be avaialble upon request from Stéphanie Vaudan stephanie.vaudan@hopitalrivierachablais.ch |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/04/2021 | 10/05/2021 | Yes | No |
Editorial Notes
10/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/04/2017: Please note that the study was registered on the same date as the recruitment start date.
