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Completed

NCT Number: NCT01554904

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

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.

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Key information

Conditions

Primary Snoring Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shands Sleep Disorders Center

Gainesville, Florida, 32606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Facial-Flex

Device

Oral exercise device

Other names: Facial Exerciser, Facial Dynamic Resistance, Neck Exerciser

Primary outcomes

  1. Snore Index

    Time frame: baseline and after 6 weeks of facial muscle training

    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).

Secondary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: baseline and after 6 weeks of facial muscle training

    The number of apneas and hypopneas per hour of monitoring

Sponsors and collaborators

Lead sponsor

Facial Concepts, Inc.

Industry

Registry information

Official study title

Facial-Flex as a Treatment for Snoring

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2012
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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