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

NCT02608840 | Completed

• 1 other identifier: STU00200555
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

slow-wave sleep; cognition; auditory stimulation

Outcome Measures

Primary Outcomes (1)

• Memory performance on a word pair recall

  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 Outcomes (1)

• NIH Cognition Toolbox - Composite score

  Through study completion, approximately 1.5 years.

Study Arms (4)

MCI auditory stimulation

EXPERIMENTAL

MCI patients receiving auditory stimulation during sleep (crossover arm 1)

Other: Auditory stimulation during sleep

MCI sham stimulation

SHAM COMPARATOR

Sham intervention: MCI patients sleeping with headphones but sounds not played (crossover arm 2)

Other: Sham Intervention

Older adult auditory stimulation

EXPERIMENTAL

healthy older adults receiving auditory stimulation during sleep (crossover arm 1)

Other: Auditory stimulation during sleep

older adult sham stimulation

SHAM COMPARATOR

Sham intervention: healthy older adults sleeping with headphones but sounds not played (crossover arm 2)

Other: Sham Intervention

Interventions

Auditory stimulation during sleep OTHER

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).

MCI auditory stimulation; Older adult auditory stimulation

Sham Intervention OTHER

The brain electroencephalogram is measured and headphones are worn, but sounds are not played during sleep.

MCI sham stimulation; older adult sham stimulation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age ≥60 years;
• 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;
• Healthy Older Adults Group: Intact cognitive profile based on neuropsychology testing within 1 standard deviation for age and education status.
• regular reported sleep and wake times

You may not qualify if:

• 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;
• unstable medical or psychiatric disorder;
• currently doing rotating shift work or night work;
• history of seizures or taking medications that may lower the seizure threshold;
• 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.
• hearing loss

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.

  PMID: 15324362 BACKGROUND

• Born J, Rasch B, Gais S. Sleep to remember. Neuroscientist. 2006 Oct;12(5):410-24. doi: 10.1177/1073858406292647.

  PMID: 16957003 BACKGROUND

• Mander BA, Rao V, Lu B, Saletin JM, Lindquist JR, Ancoli-Israel S, Jagust W, Walker MP. Prefrontal atrophy, disrupted NREM slow waves and impaired hippocampal-dependent memory in aging. Nat Neurosci. 2013 Mar;16(3):357-64. doi: 10.1038/nn.3324. Epub 2013 Jan 27.

  PMID: 23354332 BACKGROUND

• Dijk DJ, Beersma DG, van den Hoofdakker RH. All night spectral analysis of EEG sleep in young adult and middle-aged male subjects. Neurobiol Aging. 1989 Nov-Dec;10(6):677-82. doi: 10.1016/0197-4580(89)90004-3.

  PMID: 2628779 BACKGROUND

• Van Cauter E, Leproult R, Plat L. Age-related changes in slow wave sleep and REM sleep and relationship with growth hormone and cortisol levels in healthy men. JAMA. 2000 Aug 16;284(7):861-8. doi: 10.1001/jama.284.7.861.

  PMID: 10938176 BACKGROUND

• Ngo HV, Claussen JC, Born J, Molle M. Induction of slow oscillations by rhythmic acoustic stimulation. J Sleep Res. 2013 Feb;22(1):22-31. doi: 10.1111/j.1365-2869.2012.01039.x. Epub 2012 Aug 23.

  PMID: 22913273 BACKGROUND

• Tononi G, Riedner BA, Hulse BK, Ferrarelli F, Sarasso S. Enhancing sleep slow waves with natural stimuli. Medicamundi 2010;54:73-9.

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Roneil G Malkani, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 20, 2015
• Study Start: July 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)