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

NCT04875897 | Unknown

• 1 other identifier: CLN-210423-00
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  A single therapy night compared to baseline (conducted approx 1 month before the therapy night)

Secondary Outcomes (3)

• Changes in oxygen desaturation index (ODI)

  A single therapy night compared to baseline (conducted approx 1 month before the therapy night)

• Changes in arousal index (sleep quality)

  A single therapy night compared to baseline (conducted approx 1 month before the therapy night)

• Number of adverse events

  Throughout the study, an average of 2-7 days per subject

Study Arms (1)

treatment with keepMED PAP device

EXPERIMENTAL

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

Device: keepMED PAP device

Interventions

keepMED PAP device 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.).

treatment with keepMED PAP device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• keepMED Ltd.: lead
• CRI-The Clinical Research Institute GmbH: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Louis Pépin, Prof

  CHU Michallon Laboratoire EFCR CS 10217

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Charles Neuzeret, PhD

CONTACT

+49 152 554 22500; pierre-charles@keepmed.com

Alex Rapoport

CONTACT

+972 3 5170837; alex@keepmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject serves as his/her own control

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 6, 2021
• Study Start: September 14, 2021
• Primary Completion: January 15, 2022
• Study Completion: February 28, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-05