NCT00211627

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

SnoringSleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

  • Reduction/Elimination of snoring behavior

Interventions

KEEPASLEEP enhanced breathing deviceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • active oral disease
  • acute illness
  • BMI (body mass index) \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chipp St. Kevin Miller M.D.

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

SnoringSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Chipp K. Miller, M.D.

    St. Johns Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chipp K. Miller, M.D.

CONTACT

310 829-7792waycooldoc@aol.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2004

Study Completion

June 1, 2006

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

US(1)