Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness

Sleep Apnea, Obstructive Clinical Trial

Official title:

Relating Sleep Disordered Breathing to Daytime Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393913
• Other study ID #: 1357
• Secondary ID: R01HL081310-01A1
• Status: Completed
• Phase: N/A
• First received: October 30, 2006
• Last updated: August 3, 2016
• Start date: October 2006
• Est. completion date: May 2011

Study information

• Verified date: August 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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 for 4-6 weeks.

Locations

Country	Name	City	State
United States	NYU Sleep Disorders Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No