Face of Sleepiness

Obstructive Sleep Apnea Clinical Trial

— Face  

Official title:

The Face of Sleepiness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060436
• Other study ID #: HUM00028854
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: December 3, 2016
• Start date: February 2010
• Est. completion date: August 2012

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Sleep Disorders Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No