Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients

Facial Concepts, Inc.18 enrolled

Overview

The study will test the hypothesis that training with the Facial-Flex exercise device for six weeks will improve snoring in patients with primary snoring or very mild sleep apnea.

Subjects will be studied before and after 6 weeks of Facial-Flex training using portable monitoring. There will be 8 patient visits and 2 additional trips to the sleep center to return the portable sleep monitor.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Snoring Sleep Apnea

Interventions

Facial-FlexDEVICE

Oral exercise device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a history of loud snoring but no observed breathing pauses by bed partner (or only very mild obstructive sleep apnea on a previous sleep study within the prior year) will be enrolled. * Very mild sleep apnea is defined here as an apnea-hypopnea index (AHI) \< 10/hour). * This assumes that the AHI is computed using hypopnea defined as a 30% drop in the flow signal associated with a 4% or greater arterial oxygen desaturation. Exclusion Criteria: * Prior upper airway surgery * Daytime sleepiness (Epworth sleepiness scale \>12/24), (obesity BMI \> 35 kg/M2) * Significant arterial oxygen desaturation defined as 5 minutes or more with an arterial oxygen desaturation less than 88% * Severe insomnia with less than 4 hours of sleep per night * Uncontrolled psychiatric disorder * Any disorder causing facial weakness * Pregnancy * Temporal mandibular joint problems.

Locations (1)

Shands Sleep Disorders Center

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Snore Index

The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device \[Sleep Scout (ClevMed, Cleveland Ohio)\] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).

Time frame: baseline and after 6 weeks of facial muscle training

Secondary Outcomes

Apnea-Hypopnea Index (AHI)

The number of apneas and hypopneas per hour of monitoring

Time frame: baseline and after 6 weeks of facial muscle training

Data from ClinicalTrials.gov

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