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

NCT07440264 | Completed

• 2 other identifiers: UH25100814834/UN4.6.4.5.31/PP26/2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

poor sleep quality; sleep disturbance; PSQI; theta brainwave; brainwave entrainment; healthcare shift workers; qEEg; natural sound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Theta power

  Baseline (enrollment) and at 2 weeks post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Theta BWE combined with natural sound

Other: Theta brainwave entrainment combined with natural sound

Control group

SHAM COMPARATOR

BWE audio at a sham frequency

Other: BWE audio at a sham frequency

Interventions

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.

Also known as: Theta brainwave entrainment based on binaural beats, Theta binaural beats, The Theta BWE-based binaural-beat auditory stimulation

Intervention group

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.

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Universitas Hasanuddin Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Abdul Muis, dr., Sp.S(K)

  Department of Neurology, Faculty of Medicine, Universitas Hasanuddin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: October 23, 2025
• Primary Completion: January 23, 2026
• Study Completion: February 9, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)