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

UMIN ID: UMIN000048122

Registered date:25/06/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Insomnia symptoms
• Date of first enrollment: 2022/06/25
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 order of the conditions is (B, A).

Outcome(s)

• Primary Outcome: Slow wave sleep latency
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: University of Tsukuba
• Secondary Sponsor: Kyocera Corporation
• Source(s) of Monetary Support: Kyocera Corporation