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Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).   Recruitment status was  Active, not recruiting

First Received on October 30, 2006.   Last Updated on February 9, 2011   History of Changes
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00393913
  Purpose

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 purpose of this study is to evaluate the relationship between sleep-disordered breathing and levels of daytime alertness in individuals being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA.


Condition Intervention
Sleep Apnea, Obstructive
Device: Continuous Positive Airway Pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relating Sleep Disordered Breathing to Daytime Function

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Subjective sleepiness [ Time Frame: Measured at 3 months ] [ Designated as safety issue: No ]
  • Objective sleepiness [ Time Frame: Measured at 3 months ] [ Designated as safety issue: No ]
  • Vigilance [ Time Frame: Measured at 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 101
Study Start Date: October 2006
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will use a CPAP machine.
Device: Continuous Positive Airway Pressure (CPAP)
Positive airway pressure delivered via a nasal mask titrated to a therapeutic level to eliminate all sleep disordered breathing to be used every night.

Detailed Description:

Individuals with OSA can experience up to 300 sleep disruptions each night, which may result in excessive daytime sleepiness (EDS), one of the most common symptoms of OSA. EDS can have serious consequences, including motor vehicle accidents, poor school performance, and work-related accidents and performance issues. The most common treatment for OSA is CPAP therapy. This involves wearing a mask over the nose while sleeping; air then flows through the mask into the nose to maintain a level of pressure that keeps the breathing passages open. CPAP therapy typically results in fewer sleep and breathing disruptions during the night, which may increase an individual's alertness levels during the day. The purpose of this study is to evaluate the relationship between sleep-disordered breathing and daytime alertness levels in adults with symptoms of OSA who are receiving CPAP therapy.

This study will involve three to five study visits over a 2- to 3-month period. During the first 3 days, participants will record their sleep habits in a diary and will wear a device that measures breathing, oxygen levels, and sleep position. All participants will then take part in a 1-night inpatient stay at the sleep center lab during which brain, eye, muscle, heart, and breathing activity will be monitored. Participants with a confirmed diagnosis of OSA will stay at the sleep lab one additional night for observation while using a CPAP machine. The following day, tests to measure alertness, ease of falling asleep, and sleepiness levels will be administered. Participants will then use the CPAP machine at home for 4 weeks; each machine will be set at an appropriate level for the participant, and will record breathing patterns and pressure. Participants will receive weekly phone calls for monitoring purposes. At the end of Week 4, participants will return to the sleep lab for one additional night of CPAP monitoring, followed by alertness and sleep testing. Those with severe OSA will use the CPAP machine at a newly adjusted level for 5 additional days and return for repeat testing. All participants will use CPAP for 2 final weeks, and will return to the lab for overnight sleep testing without the CPAP machine and for alertness testing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393913

Locations
United States, New York
NYU Sleep Disorders Center
New York, New York, United States, 10016
Sponsors and Collaborators
Investigators
Principal Investigator: Indu Ayappa, PhD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Indu Ayappa, PhD, NYU School of Medicine
ClinicalTrials.gov Identifier: NCT00393913     History of Changes
Other Study ID Numbers: 1357, R01 HL081310-01A1
Study First Received: October 30, 2006
Last Updated: February 9, 2011
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Sleep Apnea
Sleep-Disordered Breathing
Snoring

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012