Status:
COMPLETED
Memory Consolidation in Obstructive Sleep Apnea
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The overarching goal of the research proposed here is to test the hypothesis (i) that the pathophysiological mechanisms of OSA lead to deterioration in sleep-dependent memory consolidation across memo...
Eligibility Criteria
Inclusion
- Subject selection
- General inclusion criteria:
- Men and women ages 18 to 80 years old
- Good health as determined by a medical and psychiatric history and physical examination
- An absence of any medical or psychiatric disorders (other than OSA and treated hypertension) that could influence excessive daytime sleepiness
- The ability to complete self-rating scales and computer-based testing
- Beck Depression Inventory score ≤16
- Healthy controls will be excluded with and Epworth Sleepiness Scale (ESS) score \> 10/24, OSA patients will be excluded from randomization with an ESS score \>18/24.
- Subjects must agree to abstain from alcohol consumption from the day before and throughout Session 1 and Session 2.
- Criteria for OSA patients:
- Newly diagnosed with OSA and with no prior exposure to CPAP
- Quantified apnea-hypopnea index greater than 5/hr (AHI, defined as the number of apneas and/or hypopneas per hour of sleep)
- Subjects must agree to limit alcohol use between Session 1 and Session 2 to one or fewer alcoholic drinks daily or up to 4 drinks weekly
- Criteria for Healthy control group:
- • Subjects will be matched to the obstructive sleep apnea patient group for age, race, body mass index, education and intelligence (WAIS - full scale)
- Subgroup selection:
- An additional subgroup of OSA patients and controls, who are taking antidepressants, will be recruited. Except for the current treatment with antidepressants all other exclusion and exclusion criteria will be applied.
- The following classes of antidepressants will be eligible:
- Selective serotonin reuptake inhibitors
- Serotonin-norepinephrine reuptake inhibitors
- Noradrenergic and specific serotonergic antidepressants
- Norepinephrine-dopamine reuptake inhibitors
- Exclusion criteria
- ALL PARTICIPANTS:
- Potential participants (OSA patients and controls) are excluded if one or more of the following conditions are found:
- Any history of clinically significant, uncontrolled medical or psychiatric condition (treated or untreated), other than OSA and hypertension (self-report)
- History of serious heart disease or renal failure (self-report)
- History of head injury (self-report)
- Inability to type (e.g., physical disability, arthritis) or to exercise
- A lifetime history of alcohol, narcotic or any other drug abuse (self-report)
- Use of medications, over-the counter drugs or nutritional supplements known to have an effect on sleep, cognition and/or daytime vigilance (self-report)
- Female subjects who are pregnant cannot take part in the study. If a female subject becomes pregnant during the study, she will have to stop participation
- Presence of any of the following sleep disorders:
- Cheyne-Stokes breathing or central sleep apnea (\> 10% of events central) (screening sleep study)
- Circadian rhythm disorder (structured interview)
- REM sleep without atonia or REM behavior disorder (structured interview and screening sleep study )
- Parasomnias (structured interview)
- PLMS index of \>15/h (screening sleep study)
- Insomnia (structured interview and 2 weeks sleep diaries)
- Narcolepsy (structured interview)
- Left-handedness (only MSLT participants)- (self-report)
- uncorrected vision impairment and/or visual field defect (self report, screening examination)
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01800786
Start Date
August 1 2011
End Date
June 30 2016
Last Update
June 6 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115