Clinical trial NCT00393913: Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
Official title: Relating Sleep Disordered Breathing to Daytime Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea
Sleep-Disordered Breathing
Snoring
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-10-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects coming to the NYU sleep center with complaints of sleep disordered breathing and normal controls.

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.

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 severity of sleep-disordered breathing and daytime alertness levels in adults with and withoutout symptoms of OSA.

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 4-6 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 who have been compliant with CPAP will return to the lab for overnight sleep testing without the CPAP machine and for alertness testing.

Eligibility 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

Primary outcomes:
measure: Subjective Sleepiness
timeFrame: Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)
measure: Objective Sleepiness
timeFrame: Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)
measure: Vigilance
timeFrame: Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Sleep Disorders Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Indu Ayappa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.