N/A N=18 Treatment

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

Primary Snoring · Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT01554904 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Snore Index — 348.4; 186.2 snores per hour of monitoring — p=0.02

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Facial-Flex (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Facial Concepts, Inc.
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Snore Index	348.4; 186.2	0.02 sig
SECONDARY Apnea-Hypopnea Index (AHI)	3.31; 4.16	0.22

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.

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) 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01554904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.