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

Miller, Chipp St. Kevin, M.D.

Status and phase: Unknown; Phase 1

Conditions: Snoring; Sleep Apnea Syndromes

Treatments: Device: KEEPASLEEP enhanced breathing device

Study type: Interventional

Funder types: Other

Identifiers

NCT00211627

MILC - KEEPASLEEP - 0704

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)