Sleep Optimization With Acoustic Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational University of Malaysia
About this trial
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
This trial accepts healthy volunteersQualifiers
Adults aged 18-60 years
With sleep disturbances based on the PSQI score of >5 and/or ISI score > 15
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Personalized Sound Therapy
DeviceParticipants 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparison in Sleep Architexture pre and post treatment
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.
Time frame
12 weeksSecondary outcomes
1
Comparison of Imsonia Severity Index pre and post treatment
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)
Time frame
12 weeks2
Comparison of Pittsburgh Sleep Quality Index (PSQI) pre and post treatment
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)
Time frame
12 weeks3
Comparison of Epworth Sleepiness Scale (ESS) pre and post treatment
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)
Time frame
12 weeks4
adverse events of the therapy
Adverse events will be recorded e.g headache
Time frame
12 weeksLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
National University of Malaysia, Faculty of MedicineRecruiting56000, Cheras, Kuala Lumpur
Malaysia
MalaysiaSponsors and contacts
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Source ClinicalTrials.gov