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

Not Applicable

Completed

• Conditions: Primary Snoring; Sleep Apnea

• Registration Number: NCT01554904
• Lead Sponsor: Facial Concepts, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-02-24
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-29
• Last Update Submitted: 2013-04-29
• Results First Posted: 2013-05-01
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Snore Index	baseline and after 6 weeks of facial muscle training	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).

Secondary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	baseline and after 6 weeks of facial muscle training	The number of apneas and hypopneas per hour of monitoring

Trial Locations

Locations (1)

Shands Sleep Disorders Center; 🇺🇸 Gainesville, Florida, United States