Trial Outcomes & Findings for Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients (NCT NCT01554904)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

baseline and after 6 weeks of facial muscle training

Results posted on

2013-05-01

Participant Flow

Subjects recruited at the Shands Sleep Disorders Center through posted advertisement.

The inclusion and exclusion criteria and study protocol were discussed with potential subjects. Subjects who desired to participate and met criteria signed an informed consent.

Participant milestones

Participant milestones
Measure	Facial-Flex Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Overall Study STARTED	18
Overall Study Home Sleep Study 1	18
Overall Study Start 6 Weeks of Facial Training	17
Overall Study Complete 6 Weeks of Facial Training	14
Overall Study Home Sleep Study 2	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Facial-Flex Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Overall Study Withdrawal by Subject	3
Overall Study Had sleep apnea on Home Study 1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Facial-Flex n=14 Participants Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	50.1 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and after 6 weeks of facial muscle training

Population: Subjects completing 6 weeks of training and Home Sleep Test # 2

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).

Outcome measures

Outcome measures
Measure	Facial-Flex n=14 Participants Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Snore Index Snore index Sleep study #1	348.4 snores per hour of monitoring Standard Deviation 82.3
Snore Index Snore index Sleep study #2 (after training)	186.2 snores per hour of monitoring Standard Deviation 52.2

SECONDARY outcome

Timeframe: baseline and after 6 weeks of facial muscle training

Population: Participants completing 6 weeks of training and second sleep study

The number of apneas and hypopneas per hour of monitoring

Outcome measures

Outcome measures
Measure	Facial-Flex n=14 Participants Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Apnea-Hypopnea Index (AHI) Sleep study #1 (baseline)	3.31 events per hour Standard Deviation 2.77
Apnea-Hypopnea Index (AHI) Sleep study #2 (6 weeks)	4.16 events per hour Standard Deviation 4.01

Adverse Events

Facial-Flex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard B Berry, M.D. Principal Investigator

University of Florida

Phone: 3522621575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place