Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness

NCT00393913 | Completed Results DMC

• 2 other identifiers: 1357R01HL081310-01A1
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea; Sleep-Disordered Breathing; Snoring

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Continuous Positive Airway Pressure (CPAP)

Participants will use a CPAP machine if they are found to have sleep apnea.

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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.

Continuous Positive Airway Pressure (CPAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects coming to the NYU sleep center with complaints of sleep disordered breathing and normal controls.

You may qualify if:

• Experiences symptoms of OSA, including snoring and sleepiness
• Stable medical history with no change in medications that could affect sleepiness

You may not qualify if:

• Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome)
• Medically unstable health conditions (e.g., heart attack, congestive heart failure)
• Use of psychotropic medications that cause sedation in the 3 months prior to study entry
• Recent or confirmed history of recreational drug use or alcohol abuse
• Pregnant
• Inability to communicate verbally, write, or read
• Visual, hearing, or cognitive impairment

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Sleep Disorders Center

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 23066359 RESULT

• 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.

  PMID: 23449493 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Snoring

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Indu Ayappa, PhD
• Organization: NYU School o Medicine

indu.ayappa@nyumc.org

2125628437

Study Officials

• Indu Ayappa, PhD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: October 31, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 5, 2016
• Results First Posted: January 19, 2015

Record last verified: 2016-08

Locations

US (1)