Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea (keePaOSA)

September 1, 2021 updated by: keepMED Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treatment with keepMED PAP device
Therapy night is performed with the keepMED PAP during a polysomnography in the sleep lab
Device: keepMED PAP device
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
keepMED Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CRI-The Clinical Research Institute GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Louis Pépin, Prof, CHU Michallon Laboratoire EFCR CS 10217

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLN-210423-00

Drug and device information, study documents

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

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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