Obstructive Sleep ApneaApneaBandNCT03571477
Sleep Apnea : Diagnosis and Monitoring
An observational study of Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ApneaBand
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2018to 17 Dec 2018
- How long will I take part?
- 1 Month
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with OSA and not treated for that * Non apneic subjects or unknown apneic subjects wishing to explore their sleep * Different skin tones from Fitzpatrick's phototypes I to VI.
Who may be able to join
- Patients with moderate or severe obstructive sleep apnea (OSA), diagnosed by polygraphy or PSG for less than 2 years, and not treated for that.
- Non apneic person (Berlin score = 0 or 1)
- Person be able to use the personal health monitoring device ApneaBand
- Be legally able to give consent
- Person affiliated to social security
Who cannot join
- Patient already treated for OSA
- Patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator)
- Being unable to understand and to follow recommendations for the study due to cognition or language problems
- Pregnant women, feeding and parturient
- Person under administrative or judicial control, or who is protected under the act
- Person in exclusion period for another study
- Person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.
Read the detailed description
The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.
40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).
Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ApneaBand
- Keywords
- Sleep apnea diagnosis, Sleep apnea monitoring
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaBandDevice
Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer)
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the ApneaBand to detect sleep apnea
Performance of the ApneaBand device in detecting moderate to severe sleep apnea (defined by an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour), in comparison with PSG
Measured: 3 days
Secondary outcomes (6)
Performance of the ApneaBand to mesure the apnea severity
Performance of the ApneaBand device in detecting sleep apnea according to its severity (2 pre-specified thresholds of AHI: > 5 and ≥ 30), in comparison with PSG
Measured: 3 days
External reproductibility of AHI measurement by the ApneaBand
Reproducibility between AHI from polysomnography and ApneaBand
Measured: 3 days
Internal reproductibility of AHI measurement by the ApneaBand
Reproducibility between different AHI mesures from ApneaBand
Measured: 3 days
ApneaBand algorith validation for AHI measurement
External validation of the ApneaBand algorithm
Measured: 3 days
Sleep stage detection by ApneaBand
To assess if electrodermal activity assessed by the ApneaBand during sleep is able to differerenciate the different sleep stages
Measured: 3 days
Skin tone variability
To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start15 Jun 2018
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
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.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, AIRFAN, AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Pr, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571477
- Sponsor's protocol ID
- 38RC18.010
- Acronym
- ApneaBand
- Status last verified
- Jan 2019
- First submitted
- 15 Jun 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea : Diagnosis and Monitoring
- ClinicalTrials.gov ID
- NCT03571477
- Acronym / sponsor ID
- ApneaBand / 38RC18.010
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep apnea diagnosis, Sleep apnea monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, AIRFAN, AGIR à Dom
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 27 Jun 2018 (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 prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.
Detailed description
The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.
40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).
Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with OSA and not treated for that * Non apneic subjects or unknown apneic subjects wishing to explore their sleep * Different skin tones from Fitzpatrick's phototypes I to VI.
Key inclusion criteria (5 listed)
- Patients with moderate or severe obstructive sleep apnea (OSA), diagnosed by polygraphy or PSG for less than 2 years, and not treated for that.
- Non apneic person (Berlin score = 0 or 1)
- Person be able to use the personal health monitoring device ApneaBand
- Be legally able to give consent
- Person affiliated to social security
Key exclusion criteria (7 listed)
- Patient already treated for OSA
- Patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator)
- Being unable to understand and to follow recommendations for the study due to cognition or language problems
- Pregnant women, feeding and parturient
- Person under administrative or judicial control, or who is protected under the act
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 |
|---|---|---|
| ApneaBandMesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer) | Device | – |
Primary outcome
Performance of the ApneaBand to detect sleep apnea
Time frame: 3 days
Performance of the ApneaBand device in detecting moderate to severe sleep apnea (defined by an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour), in comparison with PSG
6 secondary outcomes
Performance of the ApneaBand to mesure the apnea severity
Time frame: 3 days
External reproductibility of AHI measurement by the ApneaBand
Time frame: 3 days
Internal reproductibility of AHI measurement by the ApneaBand
Time frame: 3 days
ApneaBand algorith validation for AHI measurement
Time frame: 3 days
Sleep stage detection by ApneaBand
Time frame: 3 days
Skin tone variability
Time frame: 3 days
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 Jan 2019.
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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.
Jean-Louis PEPIN, Pr principal investigator
CHU Grenoble Alpes
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, Grenoble 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 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 4 Jan 2019. 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?
Performance of the ApneaBand to detect sleep apnea (time frame: 3 days). 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 Jan 2019.