Face of Sleepiness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan
ClinicalTrials.gov Identifier:
NCT01060436
First received: February 1, 2010
Last updated: February 8, 2012
Last verified: February 2012

February 1, 2010
February 8, 2012
February 2010
November 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01060436 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Face of Sleepiness
The Face of Sleepiness

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

University of Michigan Sleep Disorders Clinic

Obstructive Sleep Apnea
Device: CPAP or BiPAP machines
Nightly use of CPAP or BiPAP at a pressure recommended by the subject's treating physician
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
August 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01060436
HUM00028854
No
Ronald D. Chervin, M.D., M.S., University of Michigan
University of Michigan
Not Provided
Principal Investigator: Ronald D Chervin, MD, MS University of Michigan
University of Michigan
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP