Sleep ApneaRespir@domNCT01848509
Telemedicine for Sleep Apnea Patients
A study testing With teletransmission in people with Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- With teletransmission
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Sep 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI > 30/hr
- hypersomnolence
- agreement for the use of CPAP
- internet and GSM connection
Who cannot join
- central apnea >20%,
- pneumothorax,
- severe nasal obstruction,
- previous pharyngeal surgery,
- severe COPD,
- heart failure,
Show all 10Show fewer
- previous use of CPAP,
- no social security coverage,
- unavailability,
- no GSM and internet network
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris, Béclère Hospital
Clamart, 92141
About this study
Official title: A Telemedicine System for the Follow-up of Patients With SAS
Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.
Read the detailed description
The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.
- Conditions
- Sleep Apnea
- Being tested
- With teletransmission
- Keywords
- CPAP, adherence, SAOS, telemedicine
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With teletransmissionDevice
Teletransmission of alerts
| Study group | Role | What they receive |
|---|---|---|
| Without telemonitoring | No intervention | Without teletransmission of alerts |
| With telemonitoring | Experimental | With teletransmission of alerts Receives: Device: With teletransmission |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence measured by the number of hours of nightly use
Measured: 3 Months
Secondary outcomes (5)
economics: cost estimation: investment and running costs
Measured: 3 months
Quality of life
SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)
Measured: 3 months
Organizational changes of home care providers and medical structures
Measured: 9 months after the first patient inclusion
Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)
Measured: 3 months
Patients satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre ESCOURROU, MD, PhD, Principal investigator, AP-HP - Antoine Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848509
- Sponsor's protocol ID
- 2012-A00713-40
- Other IDs
- K120501
- Acronym
- Respir@dom
- Status last verified
- Dec 2014
- First submitted
- 10 Apr 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telemedicine System for the Follow-up of Patients With SAS
- ClinicalTrials.gov ID
- NCT01848509
- Acronym / sponsor ID
- Respir@dom / 2012-A00713-40
- Conditions
- Sleep Apnea
- Keywords
- CPAP, adherence, SAOS, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.
Detailed description
The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without telemonitoring | No intervention | –Without teletransmission of alerts |
| With telemonitoring | Experimental | Device: With teletransmissionWith teletransmission of alerts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AHI > 30/hr
- hypersomnolence
- agreement for the use of CPAP
- internet and GSM connection
Key exclusion criteria (10 listed)
- central apnea >20%,
- pneumothorax,
- severe nasal obstruction,
- previous pharyngeal surgery,
- severe COPD,
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 |
|---|---|---|
| With teletransmissionTeletransmission of alerts | Device | With telemonitoring |
Primary outcome
CPAP adherence measured by the number of hours of nightly use
Time frame: 3 Months
5 secondary outcomes
economics: cost estimation: investment and running costs
Time frame: 3 months
Quality of life
Time frame: 3 months
Organizational changes of home care providers and medical structures
Time frame: 9 months after the first patient inclusion
Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)
Time frame: 3 months
Patients satisfaction
Time frame: 3 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 4 Dec 2014.
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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.
Pierre ESCOURROU, MD, PhD principal investigator
AP-HP - Antoine Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With teletransmission in people with Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 10 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 4 Dec 2014. 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?
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?
CPAP adherence measured by the number of hours of nightly use (time frame: 3 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 4 Dec 2014.