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
• Interventions: Device: Facial-Flex

• 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

Arm && Interventions

Group	Intervention	Description
Facial-Flex	Facial-Flex	The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.

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