Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Miller, Chipp St. Kevin, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Miller, Chipp St. Kevin, M.D.
ClinicalTrials.gov Identifier:
NCT00211627
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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

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

ClinicalTrials.gov processed this record on May 16, 2013