Clinical Trials Logo
  1. Home
  2. Sleep Apnea Syndromes
  3. NCT00211627
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT05477719 - Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment N/A
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A
Terminated NCT02735694 - Cycloserine in the Treatment of Sleep Apnea Phase 1
Active, not recruiting NCT02470182 - Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
Completed NCT02088723 - Testing the Elevation as Sleep Apnea Treatment N/A
Completed NCT01457014 - Sleep Disordered Breathing and Chronic Pain N/A
Completed NCT00976417 - Mechanisms of Action of Adaptive Servoventilation N/A
Completed NCT00860743 - Respiratory and Autonomic Plasticity Following Intermittent Hypoxia Early Phase 1
Active, not recruiting NCT00371293 - The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease N/A
Completed NCT00607893 - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea N/A
Completed NCT00089752 - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea N/A
Completed NCT00083798 - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland N/A
Completed NCT00070681 - Outcomes of Sleep Disorders in Older Men Phase 3
Completed NCT00051363 - Apnea Positive Pressure Long-Term Efficacy Study Phase 3
Completed NCT00046670 - Sleep Disordered Breathing, APOE, and Lipid Metabolism N/A
Completed NCT00031239 - Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD N/A
Completed NCT00006323 - Neurobehavioral Consequences of Sleep Apnea in Children N/A
Terminated NCT00006321 - Neurocognitive Function in Snoring Children N/A
Completed NCT00005511 - SCOR in Neurobiology of Sleep--Intermediate Traits for Sleep Apnea N/A
Completed NCT00005275 - Sleep Heart Health Study (SHHS) Data Coordinating Center N/A