Face of Sleepiness

NCT01060436 | Completed

• 1 other identifier: HUM00028854
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea; sleep disordered breathing; CPAP; BiPAP; treatment outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

CPAP or BiPAP machines DEVICE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Michigan Sleep Disorders Clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Sleep Disorders Center

Ann Arbor, Michigan, 48109, United States

Location

Related 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.

  PMID: 23997695 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ronald D Chervin, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Michael S Aldrich Sleep Collegiate Professor of Sleep Medicine

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: August 1, 2012
• Last Updated: December 6, 2016

Record last verified: 2014-12

Locations

US (1)