Sleep Apnea, ObstructiveHYPNOSNCT03300037
HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
An observational study of Sleep Apnea, Obstructive, run by LivaNova at 5 sites in France.
Trial summary
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks: Detect apneas and hypopneas in real time, based on physiological signals acquired with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Kinesthetic stimulation
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Sep 2014to 16 Apr 2015
- 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: Severe untreated obstructive SAS patients
Who may be able to join
- above 18 years.
- Patient with diagnosed severe obstructive sleep apnea syndrome (AHI > 30/h and > 80% of obstructive events diagnosed on polysomnography or polygraphy performed less than 6 months ago )
- Patient free from CPAP treatment or any other SAS treatment for at least 3 months
- Patient with stable psychotropic medication since the diagnostic polysomnography or polygraphy exam
- Patient has signed the informed consent
Who cannot join
- Patients sleeping less than 4 hours per night
- Patients suffering from respiratory failure or periodic breathing (cheynes stokes)
- Obese patient (BMI>40kg/m2)
- Diabetic patient with autonomic dysfunction
- Vulnerable patient in accordance with article L1121-6 of CSP
- Patient with progressive malignant pathology
- Patient already involved in another clinical study that could affect the result of this study
- Pregnant patient
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Angers
Angers, 49000
Laboratoire du sommeil et d'EFCR; Hopital Michallon
Grenoble, 38043
CHU Montpellier
Montpellier
CHU Rennes
Rennes
University Hospital Tours
Tours, 37 044
About this study
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks:
- Detect apneas and hypopneas in real time, based on physiological signals acquired with a cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))
- Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of mechanoreceptors of the skin close to the mastoid bone
Read more
The primary objective is to verify that the PASITHEA system is able to detect apneas and hypopneas reliably.
The main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders.
Another objective of the study is to verify the safety of the PASITHEA system.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Kinesthetic stimulation
- 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.
Kinesthetic stimulationDevice
The kinesthetic actuator is placed on the skin near the ear and emits vibrations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events.
During the night of the recording, the PASITHEA system and the PSG will be positioned in parallel. PSG-scored events will be matched with the output of the real-time detector: a true positive event is defined as an event detected less than 10 seconds before or within the duration of a PSG-annotated events. Apneas detected as hypopneas (and reciprocally) will be regarded as true positives. Sensitivity and positive predictive value will be calculated as per conventional definintion and the 9% confidence interval will be calculated using the Wilson score.
Measured: 1 night
Secondary outcomes (1)
Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011
All adverse events will be recorded and assessed according to ISO 14155, rev 2011
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Sep 2014
- Primary completion16 Apr 2015
- Study completion16 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300037
- Sponsor's protocol ID
- IAHO02
- Acronym
- HYPNOS
- Status last verified
- Oct 2017
- First submitted
- 3 Aug 2017
- Last updated
- 3 Oct 2017
- Results posted
- 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 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
- ClinicalTrials.gov ID
- NCT03300037
- Acronym / sponsor ID
- HYPNOS / IAHO02
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Grenoble
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 16 Apr 2015 (actual)
- Study completion
- 16 Apr 2015 (actual)
- First posted
- 3 Oct 2017 (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.
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks:
- Detect apneas and hypopneas in real time, based on physiological signals acquired with a cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))
- Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of mechanoreceptors of the skin close to the mastoid bone
The primary objective is to verify that the PASITHEA system is able to detect apneas and hypopneas reliably.
The main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders.
Another objective of the study is to verify the safety of the PASITHEA system.
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
- Severe untreated obstructive SAS patients
Key inclusion criteria (5 listed)
- above 18 years.
- Patient with diagnosed severe obstructive sleep apnea syndrome (AHI > 30/h and > 80% of obstructive events diagnosed on polysomnography or polygraphy performed less than 6 months ago )
- Patient free from CPAP treatment or any other SAS treatment for at least 3 months
- Patient with stable psychotropic medication since the diagnostic polysomnography or polygraphy exam
- Patient has signed the informed consent
Key exclusion criteria (8 listed)
- Patients sleeping less than 4 hours per night
- Patients suffering from respiratory failure or periodic breathing (cheynes stokes)
- Obese patient (BMI>40kg/m2)
- Diabetic patient with autonomic dysfunction
- Vulnerable patient in accordance with article L1121-6 of CSP
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 |
|---|---|---|
| Kinesthetic stimulationThe kinesthetic actuator is placed on the skin near the ear and emits vibrations. | Device | – |
Primary outcome
Performance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events.
Time frame: 1 night
During the night of the recording, the PASITHEA system and the PSG will be positioned in parallel. PSG-scored events will be matched with the output of the real-time detector: a true positive event is defined as an event detected less than 10 seconds before or within the duration of a PSG-annotated events. Apneas detected as hypopneas (and reciprocally) will be regarded as true positives. Sensitivity and positive predictive value will be calculated as per conventional definintion and the 9% confidence interval will be calculated using the Wilson score.
1 secondary outcome
Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011
Time frame: 1 night
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 3 Oct 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by LivaNova at 5 sites 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 8 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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events. (time frame: 1 night). 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 3 Oct 2017.