Memory Consolidation in Obstructive Sleep Apnea

NCT01800786 | Completed Results

• 2 other identifiers: OSAMK23HL103850-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

OSA-CPAP group

ACTIVE COMPARATOR

OSA patient will use CPAP for 3 months

Device: CPAP

OSA -no CPAP

NO INTERVENTION

newly diagnosed OSA patient will not wear CPAP for 3 months

Interventions

CPAP DEVICE

OSA-CPAP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Ina Djonlagic
• Organization: Brigham and Women's Hospital

idjonlag@bidmc.harvard.edu

617 667 5129

Study Officials

• Ina Djonlagic, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: February 28, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: June 30, 2016
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Locations

US (1)