Obstructive Sleep ApneakeePaOSANCT04875897
Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea
A study testing keepMED PAP device in people with Obstructive Sleep Apnea, run by keepMED Ltd..
Trial summary
A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device. The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab. 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?
- keepMED PAP device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2021to 28 Feb 2022
- 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
- Age ≥18 years.
- Newly diagnosed OSA with AHI ≥ 15 events/hours.
- Indication for OSA PAP therapy in routine clinical care according to applicable medical guidelines within one month prior to study enrolment.
- Naïve to PAP therapy, i.e. even no PAP therapy during a PSG night.
- Weight > 30kg.
- Signed informed consent.
Who cannot join
- Body Mass Index (BMI) of ≤20 kg/m² or ≥ 35 kg/m².
- Pathologically low blood pressure (systolic ≤90mm Hg; diastolic ≤60 mm Hg).
- Current unstable or serious medical conditions (such as angina pectoris, myocardial infarction, cancer, stroke, dementia, congestive heart failure) which based on the physician's judgment might put the patient at high risk.
- Mixed and central apnea index ≥ 5 events/hour in PSG without PAP therapy.
- Bullous lung disease.
- Tracheostomy.
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- Pneumothorax.
- Pneumocephalus.
- Cerebrospinal fluid leak.
- Current sinus or middle ear infection.
- Persistent blockage of one or both nostrils (including nasal septum deviation and nasal polyps) or any other reason that leads to difficulty of breathing through the nose while awake.
- Any nasal, facial or head abnormalities that would not allow adequate placement of the device.
- Previous diagnosis of insomnia, narcolepsy or periodic limb movement disorder that in the judgment of the clinician could affect sleep quality assessment.
- Chronic respiratory disease (COPD, pulmonary fibrosis or asthma) or FEV/FVC ≤ 60% in history.
- History of respiratory failure.
- Supplemental oxygen is required.
- Uvulopalatopharyngoplasty or other surgical procedure to correct apnea.
- Acute respiratory infection.
- Subject recovered from Covid-19 but suffers from on-going symptoms or when subject's Covid-19 illness history can affect the study outcome based on the physician's judgment.
- Pregnancy.
- Medication that may alter sleep architecture.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: KeepMED-away-Obstructive Sleep Apnea Trial: Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea - keePaOSA
A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device.
The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab.
Secondarily, the safety of the use of the device in this setting is assessed.
Read the detailed description
The study includes a baseline visit, a habituation night, and a therapy night. Both nights will be undertaken in the sleep lab under identical conditions and will include the keepMED PAP therapy activated in parallel to polysomnography (PSG).
Baseline diagnostic PSG, performed within one month prior to enrollment to the study, will be used to assess the device efficacy.
An interim analysis to re-estimate the sample size will be performed after availability of data of 50% enrolled and treated study patients. The sample size will be re-estimated based on the observed changes of AHI in the interim analysis.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- keepMED PAP device
- 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.
keepMED PAP deviceDevice
The keepMED PAP device is an automatic, wearable positive airway pressure device indicated for treatment of obstructive sleep apnea. A therapeutic pressure is delivered to the patient upper airway through a nasal interface. It is similar to other marketed positive airway pressure devices with respect to its fundamental use of positive airway pressure for the treatment of sleep apnea as well as with regard to its functional components and accessories (e.g., a PAP unit, a mask/nasal interface, an air filter, tubing, etc.).
| Study group | Role | What they receive |
|---|---|---|
| treatment with keepMED PAP device | Experimental | Therapy night is performed with the keepMED PAP during a polysomnography in the sleep lab Receives: Device: keepMED PAP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Apnea Hypopnea Index (AHI)
Efficacy by means of changes of the AHI comparing baseline measures in a sleep lab night without keepMED PAP therapy with measures during one therapy night in a sleep lab.
Measured: A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Secondary outcomes (3)
Changes in oxygen desaturation index (ODI)
Changes in ODI comparing baseline measures in a sleep lab night without keepMED PAP therapy with measures during one therapy night in a sleep lab
Measured: A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Changes in arousal index (sleep quality)
Changes in arousal index comparing baseline measures in a sleep lab night without keepMED PAP therapy with measures during one therapy night in a sleep lab
Measured: A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Number of adverse events
Safety of the device use by means of adverse events in patients using the keepMED PAP device
Measured: Throughout the study, an average of 2-7 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start14 Sep 2021 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion28 Feb 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject serves as his/her own control
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- keepMED Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRI-The Clinical Research Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, Prof, Principal investigator, CHU Michallon Laboratoire EFCR CS 10217
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875897
- Sponsor's protocol ID
- CLN-210423-00
- Acronym
- keePaOSA
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KeepMED-away-Obstructive Sleep Apnea Trial: Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea - keePaOSA
- ClinicalTrials.gov ID
- NCT04875897
- Acronym / sponsor ID
- keePaOSA / CLN-210423-00
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- keepMED Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CRI-The Clinical Research Institute GmbH
- Study start
- 14 Sep 2021 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 6 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.
A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device.
The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab.
Secondarily, the safety of the use of the device in this setting is assessed.
Detailed description
The study includes a baseline visit, a habituation night, and a therapy night. Both nights will be undertaken in the sleep lab under identical conditions and will include the keepMED PAP therapy activated in parallel to polysomnography (PSG).
Baseline diagnostic PSG, performed within one month prior to enrollment to the study, will be used to assess the device efficacy.
An interim analysis to re-estimate the sample size will be performed after availability of data of 50% enrolled and treated study patients. The sample size will be re-estimated based on the observed changes of AHI in the interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject serves as his/her own control
| Arm | Type | Receives |
|---|---|---|
| treatment with keepMED PAP device | Experimental | Device: keepMED PAP deviceTherapy night is performed with the keepMED PAP during a polysomnography in the sleep lab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Newly diagnosed OSA with AHI ≥ 15 events/hours.
- Indication for OSA PAP therapy in routine clinical care according to applicable medical guidelines within one month prior to study enrolment.
- Naïve to PAP therapy, i.e. even no PAP therapy during a PSG night.
- Weight > 30kg.
Key exclusion criteria (21 listed)
- Body Mass Index (BMI) of ≤20 kg/m² or ≥ 35 kg/m².
- Pathologically low blood pressure (systolic ≤90mm Hg; diastolic ≤60 mm Hg).
- Current unstable or serious medical conditions (such as angina pectoris, myocardial infarction, cancer, stroke, dementia, congestive heart failure) which based on the physician's judgment might put the patient at high risk.
- Mixed and central apnea index ≥ 5 events/hour in PSG without PAP therapy.
- Bullous lung disease.
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 |
|---|---|---|
| keepMED PAP deviceThe keepMED PAP device is an automatic, wearable positive airway pressure device indicated for treatment of obstructive sleep apnea. A therapeutic pressure is delivered to the patient upper airway through a nasal interface. It is similar to other marketed positive airway pressure devices with respect to its fundamental use of positive airway pressure for the treatment of sleep apnea as well as with regard to its functional components and accessories (e.g., a PAP unit, a mask/nasal interface, an air filter, tubing, etc.). | Device | treatment with keepMED PAP device |
Primary outcome
Changes of Apnea Hypopnea Index (AHI)
Time frame: A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Efficacy by means of changes of the AHI comparing baseline measures in a sleep lab night without keepMED PAP therapy with measures during one therapy night in a sleep lab.
3 secondary outcomes
Changes in oxygen desaturation index (ODI)
Time frame: A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Changes in arousal index (sleep quality)
Time frame: A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Number of adverse events
Time frame: Throughout the study, an average of 2-7 days per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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 Pépin, Prof principal investigator
CHU Michallon Laboratoire EFCR CS 10217
Questions about this trial
What is this clinical trial studying?
A study testing keepMED PAP device in people with Obstructive Sleep Apnea, run by keepMED Ltd..
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 6 inclusion and 21 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Pierre-Charles Neuzeret, PhD (+49 152 554 22500, pierre-charles@keepmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Apnea Hypopnea Index (AHI) (time frame: A single therapy night compared to baseline (conducted approx 1 month before the therapy 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 2 Sep 2021.