Recruiting
Phase 1

KEEPASLEEP

Sponsor:

Miller, Chipp St. Kevin, M.D.

Code:

NCT00211627

Conditions

Snoring

Sleep Apnea Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

KEEPASLEEP enhanced breathing device

Study Details

Brief summary:

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

Conditions

Snoring

Sleep Apnea Syndromes

Study ID

NCT00211627

Start date

Jun, 2004

Status verified date

Sep, 2005

Completion date

Jun, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

KEEPASLEEP enhanced breathing device

Primary outcome measure

  • Reduction/Elimination of snoring behavior [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Chipp K. Miller, M.D.

310 829-7792waycooldoc@aol.com

Locations

Chipp St. Kevin Miller M.D.

Recruiting

Santa Monica, California, United States, 90404

Contacts

Chipp K. Miller, M.D.

310-829-7792waycooldoc@aol.com

More Information

Sponsor

Miller, Chipp St. Kevin, M.D.

Last update posted

Sep 21, 2005

Last verified

Sep, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Miller, Chipp St. Kevin, M.D. on 2005-09-21.