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Memory Consolidation in Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

OSA-CPAP group

OSA -no CPAP

Arm Description

OSA patient will use CPAP for 3 months

newly diagnosed OSA patient will not wear CPAP for 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2013
Last Updated
May 8, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01800786
Brief Title
Memory Consolidation in Obstructive Sleep Apnea
Official Title
Memory Consolidation in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSA-CPAP group
Arm Type
Active Comparator
Arm Description
OSA patient will use CPAP for 3 months
Arm Title
OSA -no CPAP
Arm Type
No Intervention
Arm Description
newly diagnosed OSA patient will not wear CPAP for 3 months
Intervention Type
Device
Intervention Name(s)
CPAP
Primary Outcome Measure Information:
Title
Overnight Change in Declarative Memory Performance
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ina Djonlagic, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Memory Consolidation in Obstructive Sleep Apnea

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