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

This study is currently recruiting participants.

Verified by Miller, Chipp St. Kevin, M.D., September 2005

First Received: September 13, 2005 No Changes Posted

Sponsored by:	Miller, Chipp St. Kevin, M.D.
Information provided by:	Miller, Chipp St. Kevin, M.D.
ClinicalTrials.gov Identifier:	NCT00211627

Purpose

Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

Condition	Intervention	Phase
Snoring Sleep Apnea Syndromes	Device: KEEPASLEEP enhanced breathing device	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Snoring

U.S. FDA Resources

Further study details as provided by Miller, Chipp St. Kevin, M.D.:

Primary Outcome Measures:

Reduction/Elimination of snoring behavior

Estimated Enrollment:	30
Study Start Date:	June 2004
Estimated Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211627

Contacts

Contact: Chipp K. Miller, M.D.

310 829-7792

waycooldoc@aol.com

Locations

United States, California
Chipp St. Kevin Miller M.D.	Recruiting
Santa Monica, California, United States, 90404
Contact: Chipp K. Miller, M.D. 310-829-7792 waycooldoc@aol.com

Sponsors and Collaborators

Miller, Chipp St. Kevin, M.D.

Investigators

Principal Investigator:

Chipp K. Miller, M.D.

St. Johns Health Center

More Information

No publications provided

Study ID Numbers:	MILC - KEEPASLEEP - 0704
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00211627 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Snoring
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Pathologic Processes
Disease
Respiratory Tract Diseases
Apnea
Syndrome

Nervous System Diseases
Respiration Disorders
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 02, 2009