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Memory Consolidation in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ina E. Donlagic, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01800786
First received: February 23, 2013
Last updated: May 8, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Memory Consolidation in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Ina E. Donlagic, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Overnight Change in Declarative Memory Performance [ Time Frame: 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.



Enrollment: 33
Actual Study Start Date: August 2011
Study Completion Date: June 30, 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OSA-CPAP group
OSA patient will use CPAP for 3 months
Device: CPAP
No Intervention: OSA -no CPAP
newly diagnosed OSA patient will not wear CPAP for 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800786

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ina Djonlagic, MD Brigham and Women's Hospital
  More Information

Responsible Party: Ina E. Donlagic, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01800786     History of Changes
Other Study ID Numbers: OSAM
K23HL103850-01 ( US NIH Grant/Contract Award Number )
Study First Received: February 23, 2013
Results First Received: March 10, 2017
Last Updated: May 8, 2017

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 26, 2017