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Auditory Stimulation of Slow Wave Sleep and Memory in Mild Cognitive Impairment and Older Adults

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ClinicalTrials.gov Identifier: NCT02608840
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Roneil Malkani, Northwestern University

Brief Summary:
This study will evaluate the ability of sounds played during slow wave sleep using a phase locked loop algorithm to enhance slow wave sleep and memory in cognitively healthy older adults and in those with amnestic mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: Auditory stimulation during sleep Other: Sham Intervention Not Applicable

Detailed Description:

Alzheimer's disease is a degenerative disorder associated with aging and presents a significant human and financial burden. Amnestic mild cognitive impairment (aMCI) is a disorder of impaired memory and is a precursor to Alzheimer's disease. Current treatments are symptomatic and do not slow disease progression. There is increasing evidence linking sleep and cognition, such that decreased sleep, particularly slow wave sleep (physiologically slow wave activity; SWA), is associated with impaired cognitive performance. Not only does SWA decrease with aging, it is much less in people with aMCI than cognitively normal elderly. Interventions that improve sleep may also improve cognition. Auditory stimulation using sounds played through headphones or speakers during sleep have been shown to increase SWA and memory in young adults. Because this method plays sounds at fixed intervals, its ability to enhance SWA may be limited. Investigators have developed an improved method that measures slow waves during sleep in real time and delivers the sound at a particular phase of the slow wave (phase locked loop; PLL). Given that people with aMCI have low SWA, this method may be able to improve cognition by enhancing SWA. Our objective is to determine whether the PLL method of auditory stimulation can increase SWA and improve cognition in people with aMCI. Investigators propose a randomized sham-controlled cross-over study of auditory stimulation that population.

The specific aims are:

  1. to determine a dose and duration of stimulation required to increase SWA by 10% in people with aMCI;
  2. to determine the effect of the stimulus on cognitive performance in people with aMCI using word pair recall and the NIH Toolbox cognitive battery, which includes tests in multiple cognitive domains.

Investigators will recruit 15 participants with aMCI identified through the Northwestern University Cognitive Neurology and Alzheimer's Disease Center Clinical Core. Participants will undergo 2 separate nights of polysomnography (stimulation and sham) and cognitive testing on stimulation and sham visits. There will be approximately 1 week between overnight visits. The order of stimulation and sham will be randomized. Results study will be used to determine the optimal stimulation parameters, provide preliminary data on its potential effect, and guide design of future studies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Auditory Stimulation of Slow Wave Sleep and Memory in Mild Cognitive Impairment and Older Adults
Study Start Date : July 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: MCI auditory stimulation
MCI patients receiving auditory stimulation during sleep (crossover arm 1)
Other: Auditory stimulation during sleep
The intervention is a brain computer interface program which measures brain electroencephalogram to identify slow waves and time the sounds. Barely audible sounds are delivered through headphones and played during sleep (specifically, during slow wave sleep).

Sham Comparator: MCI sham stimulation
Sham intervention: MCI patients sleeping with headphones but sounds not played (crossover arm 2)
Other: Sham Intervention
The brain electroencephalogram is measured and headphones are worn, but sounds are not played during sleep.

Experimental: Older adult auditory stimulation
healthy older adults receiving auditory stimulation during sleep (crossover arm 1)
Other: Auditory stimulation during sleep
The intervention is a brain computer interface program which measures brain electroencephalogram to identify slow waves and time the sounds. Barely audible sounds are delivered through headphones and played during sleep (specifically, during slow wave sleep).

Sham Comparator: older adult sham stimulation
Sham intervention: healthy older adults sleeping with headphones but sounds not played (crossover arm 2)
Other: Sham Intervention
The brain electroencephalogram is measured and headphones are worn, but sounds are not played during sleep.




Primary Outcome Measures :
  1. Memory performance on a word pair recall [ Time Frame: Through study completion, approximately 1.5 years. ]
    Participants will initially view word pairs on a computer screen. Participants then complete a recall, where they are presented with one word and freely recall the second word from the pair. Participants complete word pair recall prior to sleep and then again after waking in the morning. This test is completed during both experiment visits.


Secondary Outcome Measures :
  1. NIH Cognition Toolbox - Composite score [ Time Frame: Through study completion, approximately 1.5 years. ]
    Participants will complete the NIH toolbox in the morning following both experimental nights. The investigators are evaluating composite scores from the NIH Cognition Toolbox between the two nights.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women age ≥60 years;
  2. Amnestic MCI group: Diagnosis of aMCI based on change in cognition compared to the individual's previous level, impairment of episodic memory, preserved independence in functional abilities, and no evidence of impairment in social or occupational functioning;
  3. Healthy Older Adults Group: Intact cognitive profile based on neuropsychology testing within 1 standard deviation for age and education status.
  4. regular reported sleep and wake times

Exclusion Criteria:

  1. moderate-severe sleep apnea defined by apnea-hypopnea index ≥15 events/hour or periodic limb movement index ≥15/hour on the screening home sleep test;
  2. unstable medical or psychiatric disorder;
  3. currently doing rotating shift work or night work;
  4. history of seizures or taking medications that may lower the seizure threshold;
  5. current use of any sedative/hypnotics or stimulants, gabapentin, pregabalin, tricyclic antidepressants, and trazodone or other psychoactive medications that may alter slow wave sleep; however, stable (3 months or longer) use of antidepressants will be allowed.
  6. hearing loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608840


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Roneil G Malkani, MD Northwestern University

Publications:
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Responsible Party: Roneil Malkani, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02608840    
Other Study ID Numbers: STU00200555
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Roneil Malkani, Northwestern University:
slow-wave sleep
cognition
auditory stimulation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders