NCT05539378

Brief Summary

The purpose of this study is to assess the link between sleep and the clearance of waste products from the brain. This will be assessed in a group of healthy older adults.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jun 2023Jun 2027

First Submitted

Initial submission to the registry

July 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

3.4 years

First QC Date

July 20, 2022

Last Update Submit

December 4, 2024

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (5)

  • Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI

    2 weeks

  • Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI

    2 weeks

  • Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI

    2 weeks

  • Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)

    2 weeks

  • Correlation between EEG slow wave activity (uV) and tau (pg/ml)

    2 weeks

Secondary Outcomes (9)

  • Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire

    2 weeks

  • Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire

    2 weeks

  • Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)

    2 weeks

  • Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)

    2 weeks

  • Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample

    2 weeks

  • +4 more secondary outcomes

Study Arms (2)

Auditory Stimulation

EXPERIMENTAL

Auditory Stimulation during sleep

Behavioral: Auditory Stimulation

No Auditory Stimulation

SHAM COMPARATOR

Playing no tones during sleep but still recording brain activity

Behavioral: Sham (no stimulation)

Interventions

Auditory StimulationBEHAVIORAL

enhancement of sleep slow wave activity through acoustic stimulation

Auditory Stimulation
Sham (no stimulation)BEHAVIORAL

Playing no tones during sleep but still recording brain activity

No Auditory Stimulation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in previous longitudinal cohort studies at the study site
  • Ability to provide written and verbal informed consent
  • Fluency in the German language
  • Stable home situation that allows for reliable application of the intervention for the duration of the study
  • Ability to apply the intervention for the duration of the study, either alone or with support from a co-habitant
  • For women: Hormonal contraception, if menstrual cycle is still present or has been present within a year
  • Good general health status, normal cognitive function

You may not qualify if:

  • Failure or inability to give informed consent
  • Inability to follow the procedures of the investigation
  • For women: pregnancy or breastfeeding
  • Presence of sleep disorders (e.g. sleep apnoea, narcolepsy, restless leg syndrome, insomnia, rapid eye movement (REM) sleep disorder)
  • Shift-work or a home situation that requires several awakenings during the night (e.g. newborn)
  • History of serious illness likely to interfere with study outcomes
  • Presence or history of a diagnosed neuropsychiatric illness
  • Current diagnosis of uncontrolled or poorly controlled diabetes
  • Current cancer of the brain or unstable cancer undergoing treatment
  • Evidence of serious atherosclerotic cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Regenerative Medicine, University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Interventions

Acoustic Stimulationsalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

TherapeuticsSensory Art TherapiesComplementary TherapiesPhysical StimulationInvestigative Techniques

Study Officials

  • Anton Gietl

    Institute for Regenerative Medicine, University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (participant and outcomes assessor)
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2022

First Posted

September 14, 2022

Study Start

June 29, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations

CH(1)