Obstructive Sleep Apnea SyndromeSpiri+NCT04141176
Obstructive Sleep Apnea Syndrome: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
A study testing Spiri+ in people with Obstructive Sleep Apnea Syndrome, run by Sleepinnov Technology at 1 site in France.
Trial summary
Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Spiri+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2019to 23 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed and untreated Obstructive sleep apnea syndrome (IAH >15/hour) with an indication of treatment with CPAP
- Patients who have given their informed written consent
Who cannot join
- Pregnant or lactating women
- Patients not affiliated to the French social security system or equivalent
- Patient deprived of liberty by judicial or administrative decision
- Patients under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep allows improvement of symptoms related to OSAS and restores quality of life.The purpose of this study is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
Read the detailed description
Obstructive sleep apnea syndrome (OSAS) is characterized by the repetitive occurrence of partial or complete pharyngeal obstructions during sleep.Continuous Positive Airway Pressure (CPAP) is the first line treatment of OSAS.
The aim of the prospective monocentric two steps pilot study SPIRI+ is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
- the first step will validate the capability of the algorithm to appropriately detect of abnormal repiratory events during sleep.the metrics will be a comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
- the second step will check overall clinical efficacy of the new CPAP device by assessing the percentage of OSAS with an index of residual events below 10 and 5 per hour.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Spiri+
- Keywords
- Continuous positive airway pressure
- 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.
Spiri+Device
CPAP Spiri+ will be weared during one night for each included patient.The validation of the CPAP Spiri+ algorithm will be in the first 10 patients and appreciation of overall clinical efficacy on the 10 last OSAS.
| Study group | Role | What they receive |
|---|---|---|
| Spiri+ | Experimental | new CPAP device Receives: Device: Spiri+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Validation of algorithm detection of respiratory events
Comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
Measured: baseline
Part 2: Validation of overall clinical efficacy
Percentage of OSAS with an index of residual events below 10 and 5 per hour
Measured: baseline
Secondary outcomes (1)
Part 1:
Compare the different types of events detected by the Spiri + CPAP algorithm to the concomitant respective indices scored during concurrent
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start16 Nov 2019
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It's a prospective, open, monocentric study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sleepinnov Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Grenoble, ICUREsearch
- Responsible party
- Sponsor
- Investigators
- Renaud Tamisier, PhD, Principal investigator, University Hospital, GrenobleJean-Louis Pépin, PhD, Principal investigator, University Hospital, GrenobleMarie Destors, MD, Principal investigator, University Hospital, GrenobleSébastien Baillieul, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141176
- Sponsor's protocol ID
- 2018-A03014-51
- Acronym
- Spiri+
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2019
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
PubMed 27568340Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.
PubMed 27188535
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
- ClinicalTrials.gov ID
- NCT04141176
- Acronym / sponsor ID
- Spiri+ / 2018-A03014-51
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sleepinnov TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Grenoble, ICUREsearch
- Study start
- 16 Nov 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 28 Oct 2019 (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.
Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep allows improvement of symptoms related to OSAS and restores quality of life.The purpose of this study is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
Detailed description
Obstructive sleep apnea syndrome (OSAS) is characterized by the repetitive occurrence of partial or complete pharyngeal obstructions during sleep.Continuous Positive Airway Pressure (CPAP) is the first line treatment of OSAS.
The aim of the prospective monocentric two steps pilot study SPIRI+ is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
- the first step will validate the capability of the algorithm to appropriately detect of abnormal repiratory events during sleep.the metrics will be a comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
- the second step will check overall clinical efficacy of the new CPAP device by assessing the percentage of OSAS with an index of residual events below 10 and 5 per hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It's a prospective, open, monocentric study.
| Arm | Type | Receives |
|---|---|---|
| Spiri+ | Experimental | Device: Spiri+new CPAP device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosed and untreated Obstructive sleep apnea syndrome (IAH >15/hour) with an indication of treatment with CPAP
- Patients who have given their informed written consent
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients not affiliated to the French social security system or equivalent
- Patient deprived of liberty by judicial or administrative decision
- Patients under guardianship or curatorship
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 |
|---|---|---|
| Spiri+CPAP Spiri+ will be weared during one night for each included patient.The validation of the CPAP Spiri+ algorithm will be in the first 10 patients and appreciation of overall clinical efficacy on the 10 last OSAS. | Device | Spiri+ |
Primary outcome
Part 1: Validation of algorithm detection of respiratory events
Time frame: baseline
Comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
Part 2: Validation of overall clinical efficacy
Time frame: baseline
Percentage of OSAS with an index of residual events below 10 and 5 per hour
1 secondary outcome
Part 1:
Time frame: baseline
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 25 Aug 2020.
- Background: PubMed 27568340Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
- Background: PubMed 27188535Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.
- 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.
Renaud Tamisier, PhD principal investigator
University Hospital, Grenoble
Jean-Louis Pépin, PhD principal investigator
University Hospital, Grenoble
Marie Destors, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiri+ in people with Obstructive Sleep Apnea Syndrome, run by Sleepinnov Technology 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 2 inclusion and 4 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 25 Aug 2020. 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?
Part 1: Validation of algorithm detection of respiratory events (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141176, which also lists 2 linked publications.
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 25 Aug 2020.