Face of Sleepiness (Face)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060436
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : December 6, 2016
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan

Brief Summary:
The purpose of this pilot study is to find out whether successful treatment of obstructive sleep apnea makes people look less sleepy, for example by reducing swelling or dark circles under the eyes. In addition, this study will help determine whether facial photographs may be used to help identify patients who should be tested for sleep apnea and daytime sleepiness.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: CPAP or BiPAP machines

Detailed Description:

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Intervention Details:
  • Device: CPAP or BiPAP machines
    Nightly use of CPAP or BiPAP at a pressure recommended by the subject's treating physician

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University of Michigan Sleep Disorders Clinic

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01060436

United States, Michigan
University of Michigan Sleep Disorders Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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 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
treatment outcomes

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases