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Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep

Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep - Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048122
Enrollment
18
Registered
2022-06-25
Start date
2022-06-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia symptoms

Interventions

A.Sham (no sound) B.250-250.25Hz (0.25Hz binaural beat) Subjects go through a night sleep for one condition in a day (total 2 days/ each subject). The order of the conditions is (A,B). The ord

Sponsors

University of Tsukuba
Lead Sponsor
Kyocera Corporation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants will be included on the following all criteria. 1) Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms 2) Being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba. 3) Having no sleep disorder currently being treated 4) Having no hearing impairment in daily life 5) Subjectively reporting difficulty falling asleep for more than 30 minutes at least 3 times per week during the last 3 months

Exclusion criteria

Exclusion criteria: Participants will be excluded from the experiment based on the following criteria. 1) Irregular lifestyle (Regular: sleep time between 9pm and 1am, wake time between 6am and 9am) 2) BMI less than 18.5 or greater than 25 3) Worked night shifts (after 10pm) 3 months prior to the experiment 4) Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment 5) Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more) 6) Smoker 7) Consumes more than 300mg (5 cups of 150mL) of coffee every day 8) MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type) 9) Pittsburgh Sleep Quality Index score of less than 5 or Insomnia Severity Index score of less than 7. 10) Those who cannot perceive the frequency difference of the binaural beats and feel uncomfortable when listening to the auditory stimulation samples of this experiment. 11) Claustrophobic 12) Pregnancy or its possibility 13) Lactation 14) Those who have a disease that may change suddenly or its history 15) Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated 16) Suicidal ideation (item 9 on the Beck Depression Scale of greater than 2) 17) Subjects judged by the investigator to be inappropriate

Design outcomes

Primary

MeasureTime frame
Slow wave sleep latency

Secondary

MeasureTime frame
1) Sleep variables other than slow wave sleep latency obtained by polysomnography 2) Heart rate variability during sleep 3) Electroencephalogram during sleep 4) Psychomotor vigilance test performance 5) Subjective sleepiness and mood 6) Subjective reports on night sleep

Countries

Japan

Contacts

Public ContactTakashi Abe

University of Tsukuba International Institute for Integrative Sleep Medicine (WPI-IIIS)

abe.takashi.gp@u.tsukuba.ac.jp029-859-1858

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026