- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04875897
Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea (keePaOSA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre-Charles Neuzeret, PhD
- Phone Number: +49 152 554 22500
- Email: pierre-charles@keepmed.com
Study Contact Backup
- Name: Alex Rapoport
- Phone Number: +972 3 5170837
- Email: alex@keepmed.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment with keepMED PAP device
Therapy night is performed with the keepMED PAP during a polysomnography in the sleep lab
|
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.).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 ODI comparing baseline measures in a sleep lab night without keepMED PAP therapy with measures during one therapy night in a sleep lab
|
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)
|
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
|
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
|
Safety of the device use by means of adverse events in patients using the keepMED PAP device
|
Throughout the study, an average of 2-7 days per subject
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-Louis Pépin, Prof, CHU Michallon Laboratoire EFCR CS 10217
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-210423-00
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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