Back to resultsEfficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea (keePaOSA)
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
keepMED PAP device
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment with keepMED PAP device
Arm Description
Therapy night is performed with the keepMED PAP during a polysomnography in the sleep lab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Number of adverse events
Safety of the device use by means of adverse events in patients using the keepMED PAP device
Full Information
NCT ID
NCT04875897
First Posted
April 28, 2021
Last Updated
September 1, 2021
Sponsor
keepMED Ltd.
Collaborators
CRI-The Clinical Research Institute GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04875897
Brief Title
Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea
Acronym
keePaOSA
Official Title
KeepMED-away-Obstructive Sleep Apnea Trial: Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea - keePaOSA
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2021 (Anticipated)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
keepMED Ltd.
Collaborators
CRI-The Clinical Research Institute GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each subject serves as his/her own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment with keepMED PAP device
Arm Type
Experimental
Arm Description
Therapy night is performed with the keepMED PAP during a polysomnography in the sleep lab
Intervention Type
Device
Intervention Name(s)
keepMED PAP device
Intervention Description
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.).
Primary Outcome Measure Information:
Title
Changes of Apnea Hypopnea Index (AHI)
Description
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.
Time Frame
A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Secondary Outcome Measure Information:
Title
Changes in oxygen desaturation index (ODI)
Description
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
Time Frame
A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Title
Changes in arousal index (sleep quality)
Description
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
Time Frame
A single therapy night compared to baseline (conducted approx 1 month before the therapy night)
Title
Number of adverse events
Description
Safety of the device use by means of adverse events in patients using the keepMED PAP device
Time Frame
Throughout the study, an average of 2-7 days per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Charles Neuzeret, PhD
Phone
+49 152 554 22500
Email
pierre-charles@keepmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Rapoport
Phone
+972 3 5170837
Email
alex@keepmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Pépin, Prof
Organizational Affiliation
CHU Michallon Laboratoire EFCR CS 10217
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea
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