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Theta Brainwave Entrainment Combined With Natural Sound on Healthcare Shift Workers With Poor Sleep Quality: A Randomized Controlled Trial

NCT07440264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-27

No results posted yet for this study

Summary

Brief summary

The goal of this clinical trial is to investigate the effects of theta BWE combined with natural sounds on sleep quality in healthcare shift workers. The main questions it aims to answer are:

* Does theta brainwave entrainment (BWE) in combination with natural sound improve the sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) score?
* Does theta BWE in combination with natural sound change theta power based on quantitative electroencephalography (qEEG)?

Researchers will compare theta BWE combined with natural sound to a BWE audio at a sham frequency to see if theta BWE improves sleep quality.

Participants will:

* undergo baseline assessments, including the PSQI questionnaire and a quantitative Electroencephalography (qEEG), before intervention is given.
* receive theta BWE binaural beats (intervention group) or BWE audio at a sham frequency (control group) for 20-30 minutes daily for 14 days.
* be re-measured on the PSQI questionnaire and qEEG assessment after the intervention period.

Conditions

  • Poor Sleep Quality

Interventions

OTHER

Theta brainwave entrainment combined with natural sound

The Theta BWE-based binaural-beat auditory stimulation intervention will be implemented according to the following protocol. Participants in the intervention group will receive BWE audio through stereo headphones at two frequencies: binaural beats at 6 Hz (theta) and natural sounds. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success.

OTHER

BWE audio at a sham frequency

The control group participants will listen to the BWE audio through stereo headphones at a sham frequency. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success.

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Abdul Muis, dr., Sp.S(K) · Department of Neurology, Faculty of Medicine, Universitas Hasanuddin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-23
Primary Completion
2026-01-23
Completion
2026-02-09

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440264 on ClinicalTrials.gov