NCT07503223 Sleep Optimization With Acoustic Therapy
| NCT ID | NCT07503223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Malaysia |
| Condition | IMSOMNIA |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Mohamed Faisal Abdul Hamid, MBBS (IIUM)
PRINCIPAL INVESTIGATOR
National University of Malaysia
Frequently Asked Questions
Who can join the NCT07503223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying IMSOMNIA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07503223 currently recruiting?
Yes, NCT07503223 is actively recruiting participants. Contact the research team at faisal.hamid@hctm.ukm.edu.my for enrollment information.
Where is the NCT07503223 trial being conducted?
This trial is being conducted at Cheras, Malaysia.
Who is sponsoring the NCT07503223 clinical trial?
NCT07503223 is sponsored by National University of Malaysia. The principal investigator is Mohamed Faisal Abdul Hamid, MBBS (IIUM) at National University of Malaysia. The trial plans to enroll 40 participants.