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Effects of Infra- and Ultrasound on the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459183
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
Findings in neuroscientific research show that the environment one lives in has measurable effects on brain morphology and functioning. Human exposure to airborne infra- and ultrasound has been constantly increasing during the last decades. For instance, the European Renewable Energy Directive, established in 2009, lead to an increased use of wind turbines, generating infrasound. The EU Directive states that until 2020 a 20% of the EUs' total energy needs is to be generated with renewables, therefore the current infrasound load in the European environment will increase further. Similarly, ultrasound is ubiquitous in the modern public environment, emitted from public address systems, animal repellents, industrial machines, even toothbrushes. The present study aims to investigate potential long-term effects of exposure to infra- and ultrasound on subjective well-being, cognitive and brain functioning, as well as on brain structure. The study will apply a randomized-(placebo) controlled single-blind approach to investigate this subject.

Condition or disease Intervention/treatment Phase
Brain Function Ultrasound Cognitive Function Well-being Depression Sleep Device: Infrasound (85 dB; 6Hz) source Device: Ultrasound (10dB below hearing threshold; 22.4 kHz) source Device: Infrasound dummy source Device: Ultrasound dummy source Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants will not know their group assignment (ultrasound - verum, ultrasound - placebo; infrasound - verum, infrasound - placebo).
Primary Purpose: Basic Science
Official Title: Effects of Non-audible Infra- and Ultrasound on Brain Structure and -Function, Cognitive Functions, and Well-being
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Infrasound - verum
In this condition, participants are exposed with non-audible infrasound from the Infrasound (85dB; 6Hz) source, for 8 constant hours during their night sleep. The source is placed close to the participant's bed (approximately 1-2 meters).
Device: Infrasound (85 dB; 6Hz) source
the infrasound source will emit inaudible 6Hz sound for 8 consecutive hours during participant's night sleep, local sound pressure (at participants head) will be calibrated at 85 dB

Placebo Comparator: Infrasound - placebo
In this condition, participants are not exposed to any sound. The infrasound dummy source is placed close to the participant's bed, exactly like in the Infrasound - verum condition (1-2 meters). The Infrasound dummy source looks exactly like the active infrasound source but produces no sound at all. Participants are told that this source emits sound for 8 constant hours during their night sleep.
Device: Infrasound dummy source
the infrasound dummy source looks exactly like the according verum infrasound source but produces absolutely no sound

Experimental: Ultrasound - verum
In this condition, participants are exposed to non-audible ultrasound, emitted by the Ultrasound (10dB below hearing threshold; 22.4 kHz) source for 8 constant hours during their night sleep. The source is placed close to the participant's bed (1-2 meters), at the level of the participant's head (for instance on a nightstand).
Device: Ultrasound (10dB below hearing threshold; 22.4 kHz) source
the ultrasound source will emit inaudible 22.4 kHz sound for 8 consecutive hours during night sleep

Placebo Comparator: Ultrasound - placebo
In this condition, participants are not exposed to any sound. The Ultrasound dummy source is placed close to the participant's bed, exactly like in the Infrasound - verum condition (1-2 meters). The Ultrasound dummy source looks exactly like the active ultrasound source, but produces no sound at all. Participants are told that this source emits sound for 8 constant hours during their night sleep.
Device: Ultrasound dummy source
the ultrasound dummy source looks exactly like the according verum ultrasound source but produces absolutely no sound




Primary Outcome Measures :
  1. Changes in functional connectivity (functional Magnet Resonance Imaging; fMRI) [ Time Frame: at baseline (day 0) and after exposure to infra-/ ultrasound (day 28+) ]
    exploratory analyses of functional brain changes (fMRI) through infra- and ultrasound (verum conditions vs. placebo conditions)

  2. Changes in brain structure (MRI) [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    exploratory analyses of structural brain changes (MRI) through infra- and ultrasound (verum conditions vs. placebo conditions)

  3. Changes in depression levels [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    changes in Beck's Depression Inventory - II - revised sum scores, indicating a worsening or improvement (increase or decrease in sum scores) of depression through infra- and ultrasound (verum conditions vs. placebo conditions).

  4. Changes in 'vigilance' attentional test score [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    worsening or improvement in the maintenance of attention over a prolonged period of time (this is operationalized as a decrease or increase in the number of correct responses; minimum = 0, maximum = 36; assessed by TAP - Test of Attentional Performance: subtest 'vigilance') through infra- and ultrasound (verum conditions vs. placebo conditions).

  5. Changes in memory test score [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    worsening or improvement in memory performance (as indicated by the total score in the fMRI spatial n-back task, defined as the absolute number of correct responses [i.e. correct identification of overlapping dot position; minimum of correct responses = 0, maximum = 100], a decrease indicates worsened spatial memory, an increase indicates improved spatial memory; through infra- and ultrasound (verum conditions vs. placebo conditions).

  6. Changes in alertness task score [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    worsening or improvement in 'alertness' (as indicated by mean reaction time [RT] to target stimuli; higher mean RT indicates lowered alertness = worsening; lower mean RT indicates improvement in alertness, [TAP - Test of Attentional Performance; subtest 'alertness']), through infra- and ultrasound (verum conditions vs. placebo conditions).

  7. Changes in sleep quality [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    worsening or improvement in self-reported sleep quality (decreases or increases in sum score of the Pittsburgh Sleep Quality Index) through infra- and ultrasound (verum conditions vs. placebo conditions).


Secondary Outcome Measures :
  1. Changes in somatization (physical health) [ Time Frame: at baseline (day 0) and after exposure (day 28+) ]
    worsening or improvement of self-reported somatization, including cardiovascular, gastrointestinal and respiratory symptoms, as assessed via the sum score of the Brief Symptom Inventory 'somatization' subscale (increases indicate more somatization, decreases indicate less somatization; scale range for the sum score is minimum = 0; maximum = 28) through infra-/ ultrasound (vs. placebo conditions).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy participants
  • age 18-40
  • informed consent for all parts of the study (including MRT)
  • none of the exclusion criteria (see below) fulfilled
  • normal hearing

Exclusion Criteria:

  • age < 18 or > 40 years
  • pregnancy or breastfeeding
  • living with young children (0-3 years)
  • pets in sleeping room (e.g. cats, dogs, rodents, reptiles)
  • living at extremely loud/ noisy street
  • tinnitus
  • chronic disease/ infection of ENT region
  • ear deformation/ ear surgery
  • (partial) deafness
  • hearing aid/ cochlea implant
  • degenerative or inflammatory diseases of the central nervous system
  • severe cognitive/ neuropsychological impairment
  • severe pain syndrome or other severe organic diseases
  • epilepsy
  • (past or present) psychiatric disorders
  • neurological disorders
  • severe diabetic polyneuropathy
  • malignancies/ cancer
  • cardiac insufficiency
  • arterial hypertension
  • heart attack/ stroke
  • severe hepatic or renal insufficiency
  • diseases of the hemopoietic system
  • alcoholism/ drug addiction
  • medical history of severe allergic or toxic reactions
  • current participation in drug trial
  • doubts about legal capacity/ capability of understanding
  • referral to institutions based on court/ official order
  • treatment with centrally acting medication (e.g. antipsychotics, antiepileptics, antidepressants, etc.)
  • non-removable metal pieces (aneurysm clips, artificial limbs, etc.) or implanted electronic devices (pacemaker, osmotic or other implanted pumps, cochlear implants, etc.)
  • claustrophobia
  • acute (respiratory) infection, physical uneasiness
  • tattoos in the head region, permanent make-up
  • non-removable piercings

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): NCT03459183


Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Hamburg, Germany
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
European Union
Investigators
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Study Chair: Christian Koch, Dr. Physikalisch-Technische Bundesanstalt, Braunschweig, Germany
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03459183    
Other Study ID Numbers: SonicBrain01
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms