Obstructive Sleep ApneaTELEAP1NCT04897646
The TELEAP1 CPAP-telemonitoring Study
An observational study of Obstructive Sleep Apnea, run by University Hospital, Montpellier at 1 site in France.
Trial summary
TELEAP1 is a multicenter cohort pilot-study designed to evaluate the impact of a published SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm on the CPAP-compliance of newly treated patients with obstructive sleep apnea.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 15 Dec 2023
- Phase
- Observational
- 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
Study population: Patients included in the study are newly CPAP-treated with a diagnosis of obstructive sleep apnea.
Who may be able to join
- 18 years of age or older
- Patient newly CPAP-treated and eligible for care and for the reimbursement by the French Social Security rules
- Signed informed consent
Who cannot join
- Previous CPAP-treatment
- Pregnancy
- Inability to understand the nature and aims of the study or to communicate with the investigator
- Simultaneous participation in another trial with an exclusion clause to participate in another trial
- No affiliation with the French social security regime
- Loss of personal capacity resulting in state protection
- Deprivation of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
Arnaud Prigent, MD contact
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier
Dany Jaffuel, MD, PhD, 4 67 33 63 03 ext. 33, dany.jaffuel@gmail.com
About this study
Official title: Evaluation of a CPAP Telemonitoring Algorithm for Newly Treated Patients: the TELEAP1 Multicenter Cohort Pilot Study
TELEAP1 is a multicenter cohort pilot-study designed to evaluate the impact of a published SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm on the CPAP-compliance of newly treated patients with obstructive sleep apnea..
Read the detailed description
Continuous Positive Airway Pressure (CPAP)-devices can track compliance, but also leaks and residual Apnea-Hypopnea-Index (AHIflow) values. CPAP tracking systems seem intuitively useful, but there are few data demonstrating the benefit of such systems in improving CPAP-compliance and/or patients quality of life.
In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea.
In order to describe and evaluate the impact of this SFRMS/SPLF-algorithm (not only on the patient but also on the home care provider activity), a one year multicenter cohort pilot-study (TELAP1-study) was set up.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.
- Keywords
- Obstructive Sleep apnea, Continuous Positive Airway Pressure,, Telemedicine, COVID 19, observance, leaks, apnea hypopnea index.
- Medical subject headings
- Sleep Apnea, Obstructive, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.Other
In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea.
The algorithm is exhasutively described in the following published article: Prigent, A., Gentina, T., Launois, S., et al. [Telemonitoring in continuous positive airway pressure-treated patients with obstructive sleep apnoea syndrome: An algorithm proposal]. Rev. Mal. Respir., 2020, 37: 550-560.
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP-complianceversus corresponding 2019 weeks (h/days)
CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days
Measured: 4 months
Secondary outcomes (18)
AHIflow
AHIflow (events/hour) reported by the CPAP-software for the last 28 days
Measured: 4 months
CPAP-adherence
CPAP-adherence defined as the % of patients with a CPAP-adherence >4h/day, CPAP-adherence reported by the CPAP-software for the last 28 days.
Measured: 12 months
CPAP-leaks
important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days
Measured: 4 months
CPAP-leaks
important leaks (l/min or % or min/days) reported by the CPAP-software for the last 28 days
Measured: 12 months
Patient subjective sleepiness
reported by the patient using the Epworth Sleepiness Scale (0-24)
Measured: 4 months
Patient subjective sleepiness
reported by the patient using the Epworth Sleepiness Scale (0-24)
Measured: 12 months
Patient subjective depression
reported by the patient using the Pichot Depression Scale (0-13)
Measured: 12 months
Patient subjective insomnia
reported by the patient using the Insomnia Severity Scale (0-28)
Measured: 4 months
Patient subjective insomnia
reported by the patient using the Insomnia Severity Scale (0-28)
Measured: 12 months
CPAP-compliance
CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days
Measured: 12 months
Unplanned patient phone call
unplanned patient phone call with the technician regardless of the reason
Measured: Day 0 to 360
Unplanned technician phone call
unplanned technician phone call with the patient regardless of the reason
Measured: Day 0 to 360
Unplanned patient visit
unplanned patient visit to the care provider regardless of the reason
Measured: Day 0 to 360
Unplanned technician visit
unplanned technician visit to the patient regardless of the reason
Measured: Day 0 to 360
CPAP telemonitoring alarm
number and type (cpap observance < 4h for the last 7 days, and or IAHflow >10/h for the last 7 days, and or important leaks for the last 7 days)
Measured: Day 0 to 360
Interface-type change
description of the interface-type change (nasal, nasal pillows, oronasal) regardless of the reason
Measured: Day 0 to 360
Pressure settings modification
Change in the CPAP-pressure settings regardless of the reason
Measured: Day 0 to 360
CPAP-mode modification
Change in the CPAP mode (constant or auto-CPAP) regardless of the reason
Measured: Day 0 to 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 May 2021
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2023 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- ADENE, Montpellier, AGIR à dom, Meylan, ASTEN sante, Pays de la Loire, ELIA medical, Cesson-Sévigné
- Responsible party
- Sponsor
- Investigators
- Dany Jaffuel, MD,PhD, Principal investigator, Montpellier University HospitalsFréderic Gagnadoux, Study director, University Hospital, AngersArnaud Prigent, Principal investigator, Polyclinique Saint Laurent - RennesRenaud Tamisier, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897646
- Sponsor's protocol ID
- RECHMPL21_0082
- Acronym
- TELEAP1
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a CPAP Telemonitoring Algorithm for Newly Treated Patients: the TELEAP1 Multicenter Cohort Pilot Study
- ClinicalTrials.gov ID
- NCT04897646
- Acronym / sponsor ID
- TELEAP1 / RECHMPL21_0082
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep apnea, Continuous Positive Airway Pressure,, Telemedicine, COVID 19, observance, leaks, apnea hypopnea index.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- ADENE, Montpellier, AGIR à dom, Meylan, ASTEN sante, Pays de la Loire, ELIA medical, Cesson-Sévigné
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 21 May 2021 (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.
TELEAP1 is a multicenter cohort pilot-study designed to evaluate the impact of a published SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm on the CPAP-compliance of newly treated patients with obstructive sleep apnea..
Detailed description
Continuous Positive Airway Pressure (CPAP)-devices can track compliance, but also leaks and residual Apnea-Hypopnea-Index (AHIflow) values. CPAP tracking systems seem intuitively useful, but there are few data demonstrating the benefit of such systems in improving CPAP-compliance and/or patients quality of life.
In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea.
In order to describe and evaluate the impact of this SFRMS/SPLF-algorithm (not only on the patient but also on the home care provider activity), a one year multicenter cohort pilot-study (TELAP1-study) was set up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the study are newly CPAP-treated with a diagnosis of obstructive sleep apnea.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patient newly CPAP-treated and eligible for care and for the reimbursement by the French Social Security rules
- Signed informed consent
Key exclusion criteria (7 listed)
- Previous CPAP-treatment
- Pregnancy
- Inability to understand the nature and aims of the study or to communicate with the investigator
- Simultaneous participation in another trial with an exclusion clause to participate in another trial
- No affiliation with the French social security regime
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 |
|---|---|---|
| SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea. The algorithm is exhasutively described in the following published article: Prigent, A., Gentina, T., Launois, S., et al. [Telemonitoring in continuous positive airway pressure-treated patients with obstructive sleep apnoea syndrome: An algorithm proposal]. Rev. Mal. Respir., 2020, 37: 550-560. | Other | – |
Primary outcome
CPAP-complianceversus corresponding 2019 weeks (h/days)
Time frame: 4 months
CPAP-compliance (hour/day) reported by the CPAP-software for the last 28 days
18 secondary outcomes
AHIflow
Time frame: 4 months
CPAP-adherence
Time frame: 12 months
CPAP-leaks
Time frame: 4 months
CPAP-leaks
Time frame: 12 months
Patient subjective sleepiness
Time frame: 4 months
Patient subjective sleepiness
Time frame: 12 months
Patient subjective depression
Time frame: 12 months
Patient subjective insomnia
Time frame: 4 months
Patient subjective insomnia
Time frame: 12 months
CPAP-compliance
Time frame: 12 months
Unplanned patient phone call
Time frame: Day 0 to 360
Unplanned technician phone call
Time frame: Day 0 to 360
Unplanned patient visit
Time frame: Day 0 to 360
Unplanned technician visit
Time frame: Day 0 to 360
CPAP telemonitoring alarm
Time frame: Day 0 to 360
Interface-type change
Time frame: Day 0 to 360
Pressure settings modification
Time frame: Day 0 to 360
CPAP-mode modification
Time frame: Day 0 to 360
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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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.
Arnaud Prigent, MD contact
Dany Jaffuel, MD,PhD principal investigator
Montpellier University Hospitals
Fréderic Gagnadoux study director
University Hospital, Angers
Arnaud Prigent principal investigator
Polyclinique Saint Laurent - Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital, Montpellier at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dany Jaffuel, MD, PhD (+33467314840, dany.jaffuel@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP-complianceversus corresponding 2019 weeks (h/days) (time frame: 4 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 21 May 2021.