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OpenTrials
Completed

NCT Number: NCT01060436

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Sleep Disorders Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CPAP or BiPAP machines

Device

Nightly use of CPAP or BiPAP at a pressure recommended by the subject's treating physician

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

The Face of Sleepiness

Acronym: Face

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 2, 2010
Registry last updated
Dec 6, 2016

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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