IMSOMNIA, Sleep Disturbance
Conditions
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.
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
Interventions
DEVICEPersonalized 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
National University of Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison in Sleep Architexture pre and post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Imsonia Severity Index pre and post treatment | 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) |
| Comparison of Pittsburgh Sleep Quality Index (PSQI) pre and post treatment | 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) |
| Comparison of Epworth Sleepiness Scale (ESS) pre and post treatment | 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) |
| adverse events of the therapy | 12 weeks | Adverse events will be recorded e.g headache |
| adherence of the treatment received | 12 weeks | Defined as at least 80% compliance and participate in weekly remote check-ins for monitoring and support. |
Countries
Malaysia
Contacts
CONTACTMohamed Faisal Abdul Hamid, MBBS (IIUM)
PRINCIPAL_INVESTIGATORMohamed Faisal Abdul Hamid, MBBS (IIUM)
National University of Malaysia
Outcome results
None listed