ApneaNCT01852929
Sleep Apnea and Visual Perceptual Skill Learning
A study testing Subject using usual positive airway pressure therapy while sleeping for one night in people with Apnea, run by Heidi Roth, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Apnea
- What is being tested?
- Subject using usual positive airway pressure therapy while sleeping for one night
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of sleep apnea
- Use PAP therapy as prescribed by his/her physician for 3-4 weeks prior to enrollment
- Right-handed
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Hospitals Sleep Disorders Center
Chapel Hill, North Carolina, 27514
About this study
Official title: 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.
- Conditions
- Apnea
- Being tested
- Subject using usual positive airway pressure therapy while sleeping for one night
- Keywords
- Memory
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subject using usual positive airway pressure therapy while sleeping for one nightOther
Participants use their usual positive airway pressure therapy while sleeping overnight
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Subject using usual positive airway pressure therapy while sleeping for one night |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline after 6-9 hours sleep
Secondary outcomes (1)
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.
Measured: During minimum 6 hour sleep recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startNov 2009
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidi Roth, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heidi Roth, MD, University of North Carolina, Chapel Hill
- Investigators
- Heidi Roth, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852929
- Sponsor's protocol ID
- 09-1944
- Status last verified
- May 2013
- First submitted
- 25 Apr 2013
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 10771409Karni 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.
PubMed 2052578Karni 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.
PubMed 8036518Stickgold 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.
PubMed 11100141
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Apnea on Sleep Dependent Learning Using the Visual Discrimination Task.
- ClinicalTrials.gov ID
- NCT01852929
- Acronym / sponsor ID
- 09-1944
- Conditions
- Apnea
- Keywords
- Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Heidi Roth, MDUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apnea patients on and off PAP in order A | Other | Other: Subject using usual positive airway pressure therapy while sleeping for one nightSubject 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. |
| Apnea patients on and off PAP in order B | Other | Other: Subject using usual positive airway pressure therapy while sleeping for one nightSubject 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of sleep apnea
- Use PAP therapy as prescribed by his/her physician for 3-4 weeks prior to enrollment
- Right-handed
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subject using usual positive airway pressure therapy while sleeping for one nightParticipants use their usual positive airway pressure therapy while sleeping overnight | Other | Apnea patients on and off PAP in order A, Apnea patients on and off PAP in order B |
Primary outcome
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.
1 secondary outcome
Apnea Hypopnea Index (AHI)
Time frame: During minimum 6 hour sleep recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Background: PubMed 10771409Stickgold 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.
- Background: PubMed 2052578Karni 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.
- Background: PubMed 8036518Karni 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.
- Background: PubMed 11100141Stickgold 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Roth, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subject using usual positive airway pressure therapy while sleeping for one night in people with Apnea, run by Heidi Roth, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VDT learning Change Score (time frame: Change from baseline after 6-9 hours sleep). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.