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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL103850-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA-CPAP group | Active Comparator | OSA patient will use CPAP for 3 months |
|
| OSA -no CPAP | No Intervention | newly diagnosed OSA patient will not wear CPAP for 3 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Subject selection
General inclusion criteria:
Criteria for OSA patients:
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:
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:
Left-handedness (only MSLT participants)- (self-report)
uncorrected vision impairment and/or visual field defect (self report, screening examination)
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| Name | Affiliation | Role |
|---|---|---|
| Ina Djonlagic, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | OSA-CPAP Group | OSA patient will use CPAP for 3 months CPAP= continuous positive airway pressure therapy OSA= obstructive sleep apnea |
| FG001 | OSA -no CPAP | newly diagnosed OSA patient will not wear CPAP for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OSA-CPAP Group | OSA patient will use CPAP for 3 months CPAP= continuous positive airway pressure therapy OSA= obstructive sleep apnea |
| BG001 | OSA -no CPAP | newly diagnosed OSA patient will not wear CPAP for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percent change in performance | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OSA-CPAP Group | OSA patient will use CPAP for 3 months CPAP= continuous positive airway pressure therapy OSA= obstructive sleep apnea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ina Djonlagic | Brigham and Women's Hospital | 617 667 5129 | idjonlag@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | OSA -no CPAP | newly diagnosed OSA patient will not wear CPAP for 3 months | 0 | 16 | 0 | 16 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |