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

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ClinicalTrials.gov Identifier: NCT00211627
Recruitment Status : Unknown
Verified September 2005 by Miller, Chipp St. Kevin, M.D..
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Information provided by:

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

Condition or disease Intervention/treatment Phase
Snoring Sleep Apnea Syndromes Device: KEEPASLEEP enhanced breathing device Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Study Start Date : June 2004
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Reduction/Elimination of snoring behavior

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211627

Contact: Chipp K. Miller, M.D. 310 829-7792 waycooldoc@aol.com

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

ClinicalTrials.gov Identifier: NCT00211627     History of Changes
Other Study ID Numbers: MILC - KEEPASLEEP - 0704
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms