N/A
Completed N=18
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
Primary Snoring · sleep apnea
Source: ClinicalTrials.gov NCT01554904 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Snore Index — 348.4; 186.2 snores per hour of monitoring — p=0.02
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.
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 |
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.
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. Informational only — not medical advice.