Sleep Optimization With Acoustic Therapy

Recruiting now · Not applicable

Conditions studied: IMSOMNIA, Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT07503223

Run by

National University of Malaysia

People needed

40

Starts

2026-04-01

Expected to finish

2028-01-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• National University of Malaysia, Faculty of Medicine — Cheras, Kuala Lumpur, Malaysia (enrolling)

Full record on ClinicalTrials.gov

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