Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

September 13, 2005 updated by: Miller, Chipp St. Kevin, M.D.
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

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 Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Chipp St. Kevin Miller M.D.
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- 18 yrs. of age or greater

  • generally good health
  • Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development )
  • Simple snoring( documented by observer) or mild sleep apnea RDI < 15 ( documented by polysomnogram)
  • Subject must have a concerned observer to assess of sleep and snoring behavior during trial period

Exclusion Criteria:- Presence of Wisdom teeth (third molars)

  • active oral disease
  • acute illness
  • BMI (body mass index) > 30

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction/Elimination of snoring behavior

Collaborators and Investigators

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

Sponsor

Miller, Chipp St. Kevin, M.D.

Investigators

  • Principal Investigator: Chipp K. Miller, M.D., St. Johns Health Center

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

June 1, 2004

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 21, 2005

Last Update Submitted That Met QC Criteria

September 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MILC - KEEPASLEEP - 0704

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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