Back to resultsClinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Primary Purpose
Snoring, Sleep Apnea Syndromes
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KEEPASLEEP enhanced breathing device
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility 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
Sites / Locations
- Chipp St. Kevin Miller M.D.Recruiting
Outcomes
Primary Outcome Measures
Reduction/Elimination of snoring behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT00211627
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Miller, Chipp St. Kevin, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00211627
Brief Title
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Official Title
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Miller, Chipp St. Kevin, M.D.
4. Oversight
5. Study Description
Brief Summary
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Sleep Apnea Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
KEEPASLEEP enhanced breathing device
Primary Outcome Measure Information:
Title
Reduction/Elimination of snoring behavior
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chipp K. Miller, M.D.
Phone
310 829-7792
Email
waycooldoc@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chipp K. Miller, M.D.
Organizational Affiliation
St. Johns Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chipp St. Kevin Miller M.D.
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chipp K. Miller, M.D.
Phone
310-829-7792
Email
waycooldoc@aol.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
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