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

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.

Study Overview

• Status: Completed
• Conditions: Poor Sleep Quality
• Intervention / Treatment: Other: Theta brainwave entrainment combined with natural sound; Other: BWE audio at a sham frequency

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia, 90245
      • Universitas Hasanuddin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• healthcare shift workers at Universitas Hasanuddin Hospital, Makassar, Indonesia.
• healthcare shift workers for at least the past three months,
• aged 20-50 years,
• having poor sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) (>5),
• willing to participate in the entire study and sign an informed consent

Exclusion Criteria:

• having hearing impairment,
• currently taking psychotropic medications that affect sleep patterns,
• having a history of epilepsy, head trauma, or other brain disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Theta BWE combined with natural sound	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 Names: Theta brainwave entrainment based on binaural beats; Theta binaural beats; The Theta BWE-based binaural-beat auditory stimulation
Sham Comparator: Control group; BWE audio at a sham frequency	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI) score	The PSQI score will be used to assess participants' overall sleep quality. PSQI is a self-rated questionnaire comprising 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A PSQI score of more than five indicates poor sleep quality.	Baseline (enrollment) and at 2 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Theta power	Theta power is operationally defined as spectral power within the 4-8 Hz frequency range, quantified as absolute and relative theta power derived from FFT analysis of uantitative Electroencephalography (qEEG) recordings. Researchers will perform a qEEG examination using the international 10-20 system and install 19-32 electrodes on the scalp using electrodes in a lying position, record for 15 minutes with the eyes closed or open, and perform qEEG extraction to obtain the Fast Fourier Transform (FFT) theta absolute and relative power values. The measurements will be conducted before and after the intervention period.	Baseline (enrollment) and at 2 weeks post-intervention

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Study Chair: Abdul Muis, dr., Sp.S(K), Department of Neurology, Faculty of Medicine, Universitas Hasanuddin

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sleep disturbance; PSQI; brainwave entrainment; poor sleep quality; theta brainwave; healthcare shift workers; qEEg; natural sound
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: UH25100814; 834/UN4.6.4.5.31/PP26/2025 (Other Identifier: The Hasanuddin University Research Ethics Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study will be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No