Sleep Optimization With Acoustic Therapy (SONATA)

April 5, 2026 updated by: National University of Malaysia

Sleep Optimization With Acoustic Therapy: A Polysomnography-Based Pre-Post Study

Insomnia is a highly prevalent sleep disorder characterized by persistent difficulty initiating or maintaining sleep, often accompanied by impaired daytime functioning. Chronic insomnia affects approximately 10-15% of the adult population and is associated with significant physical, psychological, and socioeconomic burden. Traditional management strategies, including cognitive behavioral therapy for insomnia (CBT-I) and pharmacotherapy, have shown varying levels of effectiveness, with some patients remaining refractory to standard interventions or experiencing unwanted side effects.

Recent advances in sleep neuroscience have revealed that disturbances in endogenous brain rhythms, particularly reductions in slow-wave activity (SWA) and altered sleep spindle patterns, play a key role in the pathophysiology of insomnia. These findings have sparked interest in non-pharmacological neuromodulation approaches to restore healthy sleep architecture.

One such approach is personalized nocturnal sound frequency therapy, in which low-frequency auditory stimuli (e.g., pink noise or slow oscillation-matched tones) are delivered during sleep to entrain and enhance specific sleep-related brain oscillations. Studies in healthy individuals and patients with insomnia have demonstrated that such stimulation can augment slow-wave sleep (N3), reduce nocturnal arousals, and improve perceived sleep quality. Personalized algorithms that adapt sound delivery based on real-time EEG signals further enhance these devices' efficacy and user experience.

Despite growing evidence supporting the utility of sound-based sleep modulation, there is limited data on its application in diverse insomnia subtypes and its effect as measured by gold-standard sleep studies such as polysomnography (PSG). This study uses a pre-post PSG design to evaluate the impact of personalized sound frequency therapy on objective sleep architecture and subjective sleep outcomes in patients with insomnia. The findings may provide new insights into the therapeutic potential of acoustic brainwave modulation and support its integration into personalized insomnia care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

To evaluate the effect of daily personalized sound frequency therapy on sleep architecture (N1/N2/N3 %, REM %, total sleep time, sleep latency, sleep efficiency) measured by polysomnography after 12 weeks of intervention.

Secondary Objectives:

  • To evaluate the effect of daily personalized sound frequency therapy after 12 weeks of intervention
  • Sleep quality; using Pittsburgh Sleep Quality Index(PSQI) questionnaire ,
  • Insomnia; using Insomnia severity index(ISI) questionaire,
  • apnea-hypopnea index (AHI) assessed by polysomnography
  • daytime sleepiness; using the Epworth Sleepiness Score (ESS) intervention.
  • To assess user adherence, tolerability, and acceptability of the sound therapy.

Hypothesis There is an improvement in terms of sleep architecture, sleep quality (PSQI), insomnia severity (ISI), apnea-hypopnea index (AHI), and daytime sleepiness (ESS) with sound frequency therapy after 12 weeks of intervention.

Study Design:

A prospective, single-arm, longitudinal pre-post interventional study. Intervention duration: 12 weeks.

Baseline and follow-up PSG (full-night polysomnography).

Study Population:

Insomnia patients/hospital staff in Hospital Canselor Tuanku Muhriz UKM

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • National University of Malaysia, Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18-60 years
  • With sleep disturbances based on the PSQI score of >5 and/or ISI score > 15

Exclusion Criteria:

  • Central sleep apnea
  • Epilepsy
  • Current use of sedative-hypnotics or neurostimulation devices
  • Shift workers (people with different working hours patterns, for example morning, afternoon, night shifts)
  • Pregnancy
  • Moderate to severe OSA (AHI >15)
  • Presbycusis or other significant hearing loss
  • Patients with psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
At baseline before intervention sleep study wil be performed along with assessment of Imsomnia Severity Index Scores, Pittsburgh Sleep Quality Index (PSQI), and Eppeorth Sleepiness Score
Device: Personalized Sound Therapy
Participants will receive a wearable sound stimulation device for 12 weeks, programmed with personalized low-frequency auditory stimuli (e.g., pink noise or slow-wave-matched sounds). The patient will self-administer the therapy at home, for one hour in the morning (upon waking) and one hour in the evening (around 5 p.m. until just before sleep). The recommended device volume is above 30%, with a frequency range between 15 and 20,000 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison in Sleep Architexture pre and post treatment
Time Frame: 12 weeks
Sleep architecture refers to the structure and pattern of sleep stages recorded during overnight polysomnography. It includes Non-Rapid Eye Movement (NREM) stages (N1, N2, N3) and Rapid Eye Movement (REM) sleep. Key parameters include percentages of time spent in each stage, total sleep time (TST), sleep latency, sleep efficiency, and arousal index. It is measured at percentage of total sleep.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Imsonia Severity Index pre and post treatment
Time Frame: 12 weeks
The Insomnia Severity Index is a validated self-reported questionnaire that assesses insomnia's nature, severity, and impact over the previous month. It consists of 7 items, each scored 0-4, with total scores ranging from 0-28. Higher scores indicate greater insomnia severity. An ISI score of > 15 indicates moderate insomnia. It is measured in numbers (minimum 0- maximum 28)
12 weeks
Comparison of Pittsburgh Sleep Quality Index (PSQI) pre and post treatment
Time Frame: 12 weeks
The PSQI is a 19-item self-report questionnaire that assesses subjective sleep quality and disturbances over the past month. It yields 7 component scores, which are summed to give a global score (0-21). A score >5 indicates poor sleep quality. It is measured in numbers (minimum 0- maximum 21)
12 weeks
Comparison of Epworth Sleepiness Scale (ESS) pre and post treatment
Time Frame: 12 weeks

Epworth Sleepiness Scale (ESS) The ESS questionnaire is used to assess a patient's excessive daytime sleepiness (EDS) subjectively by rating their likelihood of dozing off during eight activities. A score of > 10 indicates excessive daytime sleepiness.

  • <10: normal
  • 11-12: mild excessive daytime sleepiness
  • 13-15: moderate excessive daytime sleepiness
  • 16-24: severe excessive daytime sleepiness It is measured in numbers (minimum 0- maximum 24)
12 weeks
adverse events of the therapy
Time Frame: 12 weeks
Adverse events will be recorded e.g headache
12 weeks
adherence of the treatment received
Time Frame: 12 weeks
Defined as at least 80% compliance and participate in weekly remote check-ins for monitoring and support.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Mohamed Faisal Abdul Hamid, MBBS (IIUM), National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2026-126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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