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

NCT ID: NCT04875897

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2022-02-28

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment with keepMED PAP device

Therapy night is performed with the keepMED PAP during a polysomnography in the sleep lab

Group Type: EXPERIMENTAL

keepMED PAP device

Intervention Type: 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.).

Interventions

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.).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CRI-The Clinical Research Institute GmbH

INDUSTRY

Sponsor Role: collaborator

keepMED Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis Pépin, Prof

Role: PRINCIPAL_INVESTIGATOR

CHU Michallon Laboratoire EFCR CS 10217

Central Contacts

Pierre-Charles Neuzeret, PhD

Role: CONTACT

pierre-charles@keepmed.com

+49 152 554 22500

Alex Rapoport

Role: CONTACT

alex@keepmed.com

+972 3 5170837

Other Identifiers

CLN-210423-00

Identifier Type: -

Identifier Source: org_study_id