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Completed

NCT Number: NCT07440264

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.

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Key information

Conditions

Poor Sleep Quality Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Hasanuddin Hospital

Makassar, South Sulawesi, 90245, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theta brainwave entrainment combined with natural sound

Other

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

BWE audio at a sham frequency

Other

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: Baseline (enrollment) and at 2 weeks post-intervention

    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.

Secondary outcomes

  1. Theta power

    Time frame: Baseline (enrollment) and at 2 weeks post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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