- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01852929
Sleep Apnea and Visual Perceptual Skill Learning
May 13, 2013 updated by: Heidi Roth, MD
The Effect of Sleep Apnea on Sleep Dependent Learning Using the Visual Discrimination Task.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27514
- UNC Hospitals Sleep Disorders Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of sleep apnea
- Use PAP therapy as prescribed by his/her physician for 3-4 weeks prior to enrollment
- Right-handed
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Apnea patients on and off PAP in order A
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.
|
Participants use their usual positive airway pressure therapy while sleeping overnight
|
|
Other: Apnea patients on and off PAP in order B
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.
|
Participants use their usual positive airway pressure therapy while sleeping overnight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VDT learning Change Score
Time Frame: Change from baseline after 6-9 hours sleep
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Apnea Hypopnea Index (AHI)
Time Frame: During minimum 6 hour sleep recording
|
The AHI is a measure of the average number of respiratory events recorded per hour of sleep based on a record which includes a minimum of 6-hours of recorded sleep.
Standard clinical categories for the severity of apnea are as follows: Mild = 5-10/ hour; Moderate = 10-15/ hour; Severe = >15/ hour.
We will measure the Apnea Hypopnea Index on the night when participants are using their standard recommended PAP therapy and on the night when they are not using that therapy in order to be able to determine how the degree of apnea (AHI) correlates with the primary outcome measure.
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During minimum 6 hour sleep recording
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heidi Roth, MD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
April 25, 2013
First Submitted That Met QC Criteria
May 13, 2013
First Posted (Estimate)
May 14, 2013
Study Record Updates
Last Update Posted (Estimate)
May 14, 2013
Last Update Submitted That Met QC Criteria
May 13, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-1944
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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