N/A
N=144
Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00393913 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Subjective Sleepiness — 11.8; 10.2; 9.9 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Continuous Positive Airway Pressure (CPAP) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Sleepiness |
11.8; 10.2; 9.9 | — |
| PRIMARY Objective Sleepiness |
6.4; 5.9; 7.8 | — |
| PRIMARY Vigilance |
5.9; 4.1; 6.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00393913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.