Clinical trial NCT01554904: Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
Official title: Facial-Flex as a Treatment for Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Snoring
Sleep Apnea
Keywords: Sleep Study
Snoring
Sleep Apnea
Muscle Laxity
Oral Appliance
Facial Muscles
Neck Muscles
Upper Airway
Muscle Strength
Dynamic Resistance
Oral Exercise
Facial Toning
Facial Muscle Strength
Strap Muscles of the Neck
Apnea-Hypopnea
Lead sponsor: Facial Concepts, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Snore Index
timeFrame: baseline and after 6 weeks of facial muscle training
Secondary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: baseline and after 6 weeks of facial muscle training
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Sleep Disorders Center
state: Florida
Study officials:
affiliation: Professor of Medicine Pulmonary, Critical Care, and Sleep Medicine University of Florida College of Medicine Chief, Pulmonary Section, Malcom Randall VAMC Medical Director, Sleep Disorders Center Shands at AGH
name: Richard B Berry, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158
citation: 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.
citation: 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