Obstructive Sleep Apnea
Conditions
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 memory systems, with the genetic marker APOε4 as a modulator, and (ii) that CPAP can reverse some or all of these measured memory deficits. In addition, we are exploring which aspects of OSA (e.g., changes in sleep architecture, measures of hypoxemia, or the EEG power spectrum) most likely impact sleep-dependent memory processing.To this end, we are using specific cognitive tasks for which sleep-dependent memory consolidation processes have previously been demonstrated by our group and others. In addition, we are carrying out quantitative EEG power spectral analyses, to delineate abnormal functioning of brain regions with more precision.
Interventions
DEVICECPAP
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Change in Declarative Memory Performance | 3 months | At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months. Positive numbers represent an increase in performance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OSA-CPAP Group OSA patient will use CPAP for 3 months
CPAP= continuous positive airway pressure therapy
OSA= obstructive sleep apnea | 17 |
| OSA -no CPAP newly diagnosed OSA patient will not wear CPAP for 3 months | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | OSA -no CPAP | OSA-CPAP Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 13 | 48.7 years STANDARD_DEVIATION 12.4 | 47.9 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
Overnight Change in Declarative Memory Performance
At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months. Positive numbers represent an increase in performance.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OSA-CPAP Group | Overnight Change in Declarative Memory Performance | 11.2 percent change in performance | Standard Deviation 0.8 |
| OSA -no CPAP | Overnight Change in Declarative Memory Performance | 6.5 percent change in performance | Standard Deviation 0.11 |