Face of Sleepiness (Face)

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: 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
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Sleep Disorders Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

University of Michigan Sleep Disorders Clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Photographic assessment of changes in facial indicators of sleepiness (ptosis, flattening or darkening of the external infraorbital surface) after PAP-treatment	2-4 months after successful nightly use of CPAP or BiPAP

Secondary Outcome Measures

Outcome Measure	Time Frame
Blinded raters provide visual assessment of relative improvement in facial images of subjects after successful PAP treatment	2-4 months after successful nightly use of CPAP or BiPAP

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Ronald D Chervin, MD, MS, University of Michigan

Publications and helpful links

General Publications

• Chervin RD, Ruzicka DL, Vahabzadeh A, Burns MC, Burns JW, Buchman SR. The face of sleepiness: improvement in appearance after treatment of sleep apnea. J Clin Sleep Med. 2013 Sep 15;9(9):845-52. doi: 10.5664/jcsm.2976.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 3, 2016
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: CPAP; sleep apnea; treatment outcomes; BiPAP; sleep disordered breathing
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
• Other Study ID Numbers: HUM00028854