Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
Relating Sleep Disordered Breathing to Daytime Function
Sponsor study identifier
Secondary identifiers
observational
144
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing, or experiences shallow breathing for short periods of time during sleep. Daytime sleepiness is a common symptom of OSA and may affect an individual's level of alertness throughout the day. The primary purpose of this study is to evaluate the relationship between the severity of sleep-disordered breathing and levels of daytime alertness at baseline (untreated state) in a group of subjects with and without sleep apnea. In addition the change in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 30, 2006
Actual (reported)October 31, 2006
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)January 19, 2015
Actual (reported)Subjective Sleepiness
Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.
Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)
Objective Sleepiness
Multiple Sleep Latency Test (MSLT) measures the latency to sleep onset in minutes. The shorter the latency to sleep the more sleepy the subject.
Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)
Vigilance
Vigilance is measured using the psychomotor vigilance task which is a portable reaction time test that is contained in a small, programmable, portable electronic box that requires only a single switch to start. The task consists of responding to a small bright red light stimulus by pressing a response button as soon as the stimulus appears. This stops the stimulus counter and displays the reaction time (RT) in milliseconds for a 2-second period and the task duration is 20 minutes. The subject is instructed to press the button as soon as each stimulus appears in order to keep the reaction time as low as possible. The PVT yields highly informative metrics on the capacity for sustained attention including the frequency of lapses (reaction time \> 500 milliseconds). The higher the number of lapses the greater the impairment. Well rested (non-sleepy) subjects have almost no lapses(\<2) during the 20min test.
Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)
Participants will use a CPAP machine if they are found to have sleep apnea.
Positive airway pressure delivered via a nasal mask titrated to a therapeutic level to eliminate all sleep disordered breathing to be used every night for 4-6 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects coming to the NYU sleep center with complaints of sleep disordered breathing and normal controls.
NYU Sleep Disorders Center
New York, New York, 10016, United States
Somiah M, Taxin Z, Keating J, Mooney AM, Norman RG, Rapoport DM, Ayappa I. Sleep quality, short-term and long-term CPAP adherence. J Clin Sleep Med. 2012 Oct 15;8(5):489-500. doi: 10.5664/jcsm.2138.
Young LR, Taxin ZH, Norman RG, Walsleben JA, Rapoport DM, Ayappa I. Response to CPAP withdrawal in patients with mild versus severe obstructive sleep apnea/hypopnea syndrome. Sleep. 2013 Mar 1;36(3):405-12. doi: 10.5665/sleep.2460.
Indu Ayappa, PhD
NYU School of Medicine
144 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2006
First Posted
October 31, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Obstructive Sleep Apnea and Genes Expression
Contact the study team to confirm eligibility.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
August 5, 2016
Results First Posted
January 19, 2015
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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