Text Size

Face of Sleepiness

This study is ongoing, but not recruiting participants.
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
History of Changes
  Purpose

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 Intervention
Obstructive Sleep Apnea
 Device: CPAP or BiPAP machines

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Face of Sleepiness

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: February 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CPAP or BiPAP machines
    Nightly use of CPAP or BiPAP at a pressure recommended by the subject's treating physician
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University of Michigan Sleep Disorders Clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060436

Locations
United States, Michigan
University of Michigan Sleep Disorders Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ronald D Chervin, MD, MS University of Michigan
  More Information

Publications:

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
Study First Received: February 1, 2010
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Michigan:
sleep apnea
sleep disordered breathing
CPAP
BiPAP
treatment outcomes

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013