Face of Sleepiness - Full Text View

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
Study Completion Date:	August 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

Lee RW, Petocz P, Prvan T, Chan AS, Grunstein RR, Cistulli PA. Prediction of obstructive sleep apnea with craniofacial photographic analysis. Sleep. 2009 Jan;32(1):46-52.

Lee RW, Chan AS, Grunstein RR, Cistulli PA. Craniofacial phenotyping in obstructive sleep apnea--a novel quantitative photographic approach. Sleep. 2009 Jan;32(1):37-45.


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:	December 31, 2014
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:


Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases	Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016

Face of Sleepiness (Face)