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

November 4, 2019 updated by: Roneil Malkani, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, approximately 1.5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, approximately 1.5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Roneil G Malkani, MD, Northwestern University

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

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

July 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00200555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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