Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04861038 · ClinicalTrials.gov registry record · NA

Study Using Negative Pressure to Reduce Apnea

A NA study of Sleep Apnea, Obstructive and Apnea, Sleep, sponsored by Sommetrics.

Active
Registry status
NA
Development phase
900
Enrollment target
15
Study locations

NCT04861038 is a NA study of Sleep Apnea, Obstructive and Apnea, Sleep that is active but no longer recruiting, run by Sommetrics. The registered enrollment target is 900 participants, above the 242-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (272% higher). The trial reports 15 study locations across 10 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04861038, a NA study of Sleep Apnea, Obstructive and Apnea, Sleep, is active but no longer recruiting, sponsored by Sommetrics.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
900 participants
Enrollment target
15
Study locations

Study Summary

The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) therapy.

Conditions Studied

Sleep Apnea, Obstructive Apnea, Sleep

Interventions

  • DEVICE aerSleep II

Study Locations (15)

Ohio

  • The MetroHealth System - Cleveland
  • Cleveland Clinic Foundation - Cleveland
  • The Ohio State University - Columbus

California

  • Infinitive Bioresearch - Los Angeles
  • BetterNight - San Diego

Pennsylvania

  • Thomas Jefferson University - Philadelphia
  • UPMC - Pittsburgh

South Carolina

  • Bogan Sleep Consultants - Columbia
  • BioSerenity - Columbia

Arizona

  • University of Arizona - Tucson

Arkansas

  • Preferred Research Partners - Little Rock

Colorado

  • Delta Waves - Colorado Springs

Florida

  • Baptist Hospital - Miami

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2021-11-29
Est. Completion 2025-12
Phase NA

Sponsor

Sommetrics

3 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04861038

The ClinicalTrials.gov registry entry for NCT04861038 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 242-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (272% higher). The listed sponsor is Sommetrics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 1 intervention - of which aerSleep II is the first listed.

NCT04861038 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Ohio, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04861038 about?

NCT04861038 is a clinical study titled "Study Using Negative Pressure to Reduce Apnea". The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) t...

What is the current status of trial NCT04861038?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 900 participants. The study started on 2021-11-29. Estimated completion is 2025-12.

What conditions does trial NCT04861038 study?

This clinical trial studies the following conditions: Sleep Apnea, Obstructive, Apnea, Sleep.

What interventions are being tested in trial NCT04861038?

The interventions under investigation include: aerSleep II (DEVICE).

Who is sponsoring clinical trial NCT04861038?

This trial is sponsored by Sommetrics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04861038 being conducted?

This trial has 15 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Sleep Apnea, Obstructive

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Sleep Apnea, Obstructive

All registered trials for this condition

Apnea, Sleep

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.