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

NCT ID: NCT00211627

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Snoring Sleep Apnea Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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KEEPASLEEP enhanced breathing device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* active oral disease
* acute illness
* BMI (body mass index) \> 30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Miller, Chipp St. Kevin, M.D.

OTHER

Sponsor Role lead

Principal Investigators

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Chipp K. Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Johns Health Center

Locations

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Chipp St. Kevin Miller M.D.

Santa Monica, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chipp K. Miller, M.D.

Role: CONTACT

Phone: 310 829-7792

Email: [email protected]

Facility Contacts

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Chipp K. Miller, M.D.

Role: primary

Other Identifiers

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MILC - KEEPASLEEP - 0704

Identifier Type: -

Identifier Source: org_study_id