Face of Sleepiness (Face)
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ClinicalTrials.gov Identifier: NCT01060436 |
Recruitment Status
:
Completed
First Posted
: February 2, 2010
Last Update Posted
: December 6, 2016
|
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Condition or disease | Intervention/treatment |
---|---|
Obstructive Sleep Apnea | Device: CPAP or BiPAP machines |
The main symptom of nocturnal sleep disorders is often excessive daytime sleepiness. Although sleepiness can be a major contributor to decreased quality of life, and even mortality, patients frequently grow habituated to their sleepiness, ignoring it and any underlying disorder. One scarcely explored potential consequence that could motivate patients to address sleep disorders is a sleepy facial appearance. No peer-reviewed literature, to our knowledge, has explored whether inadequate or insufficient sleep actually causes changes facial appearance. No published literature has examined the extent to which treatment for sleep disorders might improve such facial changes, and perhaps motivate patients to treat their sleep disorders.
To address these questions in a preliminary manner, therefore, the investigators propose to use cutting-edge photographic technology to assess subtle changes in facial appearance. The investigators will recruit 20 sleepy adult patients who are diagnosed with obstructive sleep apnea, an ideal disease model in which subjects can be tested before and after alleviation of severe sleepiness by home use of continuous positive airway pressure. Results of this pilot study could show for the first time that successful treatment of a chronic sleep disorder improves facial features commonly perceived as an undesirable sign of sleepiness.
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Face of Sleepiness |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | August 2012 |

-
Device: CPAP or BiPAP machines
- Photographic assessment of changes in facial indicators of sleepiness (ptosis, flattening or darkening of the external infraorbital surface) after PAP-treatment [ Time Frame: 2-4 months after successful nightly use of CPAP or BiPAP ]
- Blinded raters provide visual assessment of relative improvement in facial images of subjects after successful PAP treatment [ Time Frame: 2-4 months after successful nightly use of CPAP or BiPAP ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults, age 18-65
- Recently diagnosed with obstructive sleep apnea, confirmed by polysomnography (sleep study)
- Experiencing daytime sleepiness, based on Epworth Sleepiness Scale
- Scheduled for a positive airway pressure (PAP) titration study (CPAP or BiPAP)
- Willing to use CPAP or BiPAP at pressures prescribed by the treating physician
- Willing to have facial photographs taken before treatment and 2-4 months after nightly use of CPAP or BiPAP
Exclusion Criteria:
- Diagnosed with other sleep, medical or psychiatric disorders that might limit the effectiveness of PAP treatment (such as morbid obesity, emphysema, and neurodegenerative disorders)
- Conditions that may cause daytime sleepiness (such as narcolepsy, primary insomnia, seizure disorders, or major depression)
- Use of medications or herbal remedies that affect sleep and behavior
- History of facial plastic or reconstructive surgery or Botox injections or plans to undergo these types of treatments prior to completing the second study visit

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060436
United States, Michigan | |
University of Michigan Sleep Disorders Center | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Ronald D Chervin, MD, MS | University of Michigan |
Publications of Results:
Responsible Party: | Ronald D. Chervin, M.D., M.S., Professor of Neurology and Michael S Aldrich Sleep Collegiate Professor of Sleep Medicine, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01060436 History of Changes |
Other Study ID Numbers: |
HUM00028854 |
First Posted: | February 2, 2010 Key Record Dates |
Last Update Posted: | December 6, 2016 |
Last Verified: | December 2014 |
Keywords provided by Ronald D. Chervin, M.D., M.S., University of Michigan:
sleep apnea sleep disordered breathing CPAP BiPAP treatment outcomes |
Additional relevant MeSH terms:
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |