Sleep Optimization With Acoustic Therapy

Summary

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.

Conditions

• IMSOMNIA
• Sleep Disturbance

Interventions

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

Sponsors & Collaborators

• National University of Malaysia

  lead OTHER

Principal Investigators

• Mohamed Faisal Abdul Hamid, MBBS (IIUM) · National University of Malaysia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-01-01

Completion

2028-01-01

Countries

• Malaysia