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NCT00211627 Clinical Trial

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

Sleep Apnea Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00211627
Other study ID # MILC - KEEPASLEEP - 0704
Secondary ID
Status Recruiting
Phase Phase 1
First received September 13, 2005
Last updated September 13, 2005
Start date June 2004
Est. completion date June 2006

Study information
Verified date September 2005
Source Miller, Chipp St. Kevin, M.D.
Contact Chipp K. Miller, M.D.
Phone 310 829-7792
Email waycooldoc@aol.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Device:
• KEEPASLEEP enhanced breathing device

Locations
Country Name City State
United States Chipp St. Kevin Miller M.D. Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
Miller, Chipp St. Kevin, M.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction/Elimination of snoring behavior
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