NCT01852929

Brief Summary

The purpose of this study is to determine whether obstructive sleep apnea affects sleep dependent memory and learning. Subjects with apnea will be given a test of perceptual skill learning (the Visual Discrimination Task (VDT)) that has previously been shown to depend on sleep. Subjects will be tested on this task before and after sleep. The difference in performance after sleep compared to before sleep provides a measure of sleep dependent learning. Participants will be tested on one night when they have less apnea because they are using continuous positive airway pressure (CPAP) as prescribed by their physician, which is well known to reduce apnea; and on another night when they are in their native state and have a greater degree of apnea. Memory performance will be compared between the two nights to determine how apnea affects sleep dependent memory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

2.4 years

First QC Date

April 25, 2013

Last Update Submit

May 13, 2013

Conditions

Keywords

Memory

Outcome Measures

Primary Outcomes (1)

  • VDT learning Change Score

    Learning on the visual discrimination task (VDT) is measured by comparing performance on the perceptual task at a baseline session prior to sleep to that in a second session after sleep. Subjects are standardly tested in the hour prior to their typical bedtime, and re-tested after spontaneously awakening after a night of sleep. Sleep is known to consolidate learning on this task, such that more robust learning occurs after an interval of sleep compared to when the patient is awake over the same interval (Stickgold et al, J Cog Neurosci,2000; Stickgold et al., Nat Neurosci, 2000). Our aim is to determine if sleep dependent learning is disrupted by apnea, and preserved when apnea is eliminated.

    Change from baseline after 6-9 hours sleep

Secondary Outcomes (1)

  • Apnea Hypopnea Index (AHI)

    During minimum 6 hour sleep recording

Study Arms (2)

Apnea patients on and off PAP in order A

OTHER

Subject using usual positive airway pressure therapy while sleeping for one night, then crossing over to not using usual apnea therapy while sleeping for another night.

Other: Subject using usual positive airway pressure therapy while sleeping for one night

Apnea patients on and off PAP in order B

OTHER

Subject not using apnea therapy while sleeping for one night, then crossing over and subject using usual positive airway pressure therapy while sleeping for one night.

Other: Subject using usual positive airway pressure therapy while sleeping for one night

Interventions

Participants use their usual positive airway pressure therapy while sleeping overnight

Apnea patients on and off PAP in order AApnea patients on and off PAP in order B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of sleep apnea
  • Use PAP therapy as prescribed by his/her physician for 3-4 weeks prior to enrollment
  • Right-handed

You may not qualify if:

  • Major neurological or psychiatric condition
  • Chronic pain condition
  • Learning disabilities
  • Serious brain or head injury (e.g. seizure, stroke, head trauma)
  • Major surgery or general anesthesia in the past year
  • Pregnant or nursing
  • Problems with eyes or vision (besides corrected-to-normal with glasses or contacts)
  • Past diagnosis of infection that can affect the brain (e.g. meningitis, HIV/AIDS)
  • Medications that affect sleep (antidepressants, muscle relaxants, sleep aids, beta-blockers, stimulants, or corticosteroids)
  • Recreational drug use, including marijuana
  • Night-shift work
  • Cancer or cancer treatment in the last 2 years
  • Smoke more than 10 cigarettes per day
  • Consume more than 3 caffeinated foods or beverages per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Hospitals Sleep Disorders Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (4)

  • Stickgold R, Whidbee D, Schirmer B, Patel V, Hobson JA. Visual discrimination task improvement: A multi-step process occurring during sleep. J Cogn Neurosci. 2000 Mar;12(2):246-54. doi: 10.1162/089892900562075.

    PMID: 10771409BACKGROUND
  • Karni A, Sagi D. Where practice makes perfect in texture discrimination: evidence for primary visual cortex plasticity. Proc Natl Acad Sci U S A. 1991 Jun 1;88(11):4966-70. doi: 10.1073/pnas.88.11.4966.

    PMID: 2052578BACKGROUND
  • Karni A, Tanne D, Rubenstein BS, Askenasy JJ, Sagi D. Dependence on REM sleep of overnight improvement of a perceptual skill. Science. 1994 Jul 29;265(5172):679-82. doi: 10.1126/science.8036518.

    PMID: 8036518BACKGROUND
  • Stickgold R, James L, Hobson JA. Visual discrimination learning requires sleep after training. Nat Neurosci. 2000 Dec;3(12):1237-8. doi: 10.1038/81756. No abstract available.

    PMID: 11100141BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heidi Roth, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

April 25, 2013

First Posted

May 14, 2013

Study Start

November 1, 2009

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations