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

Sleep Apnea Clinical Trial

Official title:

Facial-Flex as a Treatment for Snoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554904
• Other study ID #: Protocol 0102011
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: April 29, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Facial Concepts, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Snoring
• Sleep Apnea
• Snoring

Intervention

Device:
• Facial-Flex
Oral exercise device

Locations

Country	Name	City	State
United States	Shands Sleep Disorders Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Facial Concepts, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barry M. Zide, M.D.; James P. Bradley, M.D.;Michael T. Longaker, M.D. Institute of Reconstructive Plastic Surgery at New York University Medical Ctr. Plastic Reconstructive Surgery 2000 March;1154-1158

Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158

van Lieshout PH, Bose A, Namasivayam AK. Physiological effects of an 8-week mechanically aided resistance facial exercise program. Int J Orofacial Myology. 2002 Nov;28:49-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline and after 6 weeks of facial muscle training	No
Secondary	Apnea-Hypopnea Index (AHI)	The number of apneas and hypopneas per hour of monitoring	baseline and after 6 weeks of facial muscle training	No