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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01852929
Other study ID # 09-1944
Secondary ID
Status Completed
Phase N/A
First received April 25, 2013
Last updated May 13, 2013
Start date November 2009
Est. completion date May 2012

Study information

Verified date May 2013
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Subject using usual positive airway pressure therapy while sleeping for one night
Participants use their usual positive airway pressure therapy while sleeping overnight

Locations

Country Name City State
United States UNC Hospitals Sleep Disorders Center Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Heidi Roth, MD

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Stickgold R, James L, Hobson JA. Visual discrimination learning requires sleep after training. Nat Neurosci. 2000 Dec;3(12):1237-8. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Apnea Hypopnea Index (AHI) 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. During minimum 6 hour sleep recording No
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