IMSOMNIASONATANCT07503223
Sleep Optimization With Acoustic Therapy
A study testing Personalized Sound Therapy in people with IMSOMNIA and Sleep Disturbance, run by National University of Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- IMSOMNIA, Sleep Disturbance
- What is being tested?
- Personalized Sound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-60 years
- With sleep disturbances based on the PSQI score of >5 and/or ISI score > 15
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
National University of Malaysia, Faculty of Medicine
Cheras, Kuala Lumpur, 56000
Mohamed Faisal Abdul Hamid, 0391455555, faisal.hamid@ppukm.ukm.edu.my
About this study
Official title: Sleep Optimization With Acoustic Therapy: A Polysomnography-Based Pre-Post Study
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.
Read more
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.
Read the 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
- Conditions
- IMSOMNIA, Sleep Disturbance
- Being tested
- Personalized Sound Therapy
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Sound TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | At baseline before intervention sleep study wil be performed along with assessment of Imsomnia Severity Index Scores, Pittsburgh Sleep Quality Index (PSQI), and Eppeorth Sleepiness Score Receives: Device: Personalized Sound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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)
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
adverse events of the therapy
Adverse events will be recorded e.g headache
Measured: 12 weeks
adherence of the treatment received
Defined as at least 80% compliance and participate in weekly remote check-ins for monitoring and support.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for IMSOMNIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Faisal Abdul Hamid, MBBS (IIUM), Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503223
- Sponsor's protocol ID
- FF-2026-126
- Acronym
- SONATA
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lustenberger C, Maric A, Durr R, Achermann P, Huber R. Triangular relationship between sleep spindle activity, general cognitive ability and the efficiency of declarative learning. PLoS One. 2012;7(11):e49561. doi: 10.1371/journal.pone.0049561. Epub 2012 Nov 21.
PubMed 23185361Baglioni C, Spiegelhalder K, Lombardo C, Riemann D. Sleep and emotions: a focus on insomnia. Sleep Med Rev. 2010 Aug;14(4):227-38. doi: 10.1016/j.smrv.2009.10.007. Epub 2010 Feb 6.
PubMed 20137989Perlis ML, Giles DE, Mendelson WB, Bootzin RR, Wyatt JK. Psychophysiological insomnia: the behavioural model and a neurocognitive perspective. J Sleep Res. 1997 Sep;6(3):179-88. doi: 10.1046/j.1365-2869.1997.00045.x.
PubMed 9358396Riemann D, Krone LB, Wulff K, Nissen C. Sleep, insomnia, and depression. Neuropsychopharmacology. 2020 Jan;45(1):74-89. doi: 10.1038/s41386-019-0411-y. Epub 2019 May 9.
PubMed 31071719Ngo HV, Martinetz T, Born J, Molle M. Auditory closed-loop stimulation of the sleep slow oscillation enhances memory. Neuron. 2013 May 8;78(3):545-53. doi: 10.1016/j.neuron.2013.03.006. Epub 2013 Apr 11.
PubMed 23583623Leminen MM, Virkkala J, Saure E, Paajanen T, Zee PC, Santostasi G, Hublin C, Muller K, Porkka-Heiskanen T, Huotilainen M, Paunio T. Enhanced Memory Consolidation Via Automatic Sound Stimulation During Non-REM Sleep. Sleep. 2017 Mar 1;40(3):zsx003. doi: 10.1093/sleep/zsx003.
PubMed 28364428Ong JL, Lo JC, Chee NI, Santostasi G, Paller KA, Zee PC, Chee MW. Effects of phase-locked acoustic stimulation during a nap on EEG spectra and declarative memory consolidation. Sleep Med. 2016 Apr;20:88-97. doi: 10.1016/j.sleep.2015.10.016. Epub 2015 Nov 27.
PubMed 27318231Arnal PJ, Thorey V, Debellemaniere E, Ballard ME, Bou Hernandez A, Guillot A, Jourde H, Harris M, Guillard M, Van Beers P, Chennaoui M, Sauvet F. The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging. Sleep. 2020 Nov 12;43(11):zsaa097. doi: 10.1093/sleep/zsaa097.
PubMed 32433768Aloulou A, Chauvineau M, Destexhe A, Leger D. Listening to the sound of your own brain waves enhances sleep quality and quantity. Sleep Med. 2025 Dec;136:106755. doi: 10.1016/j.sleep.2025.106755. Epub 2025 Aug 15.
PubMed 40962569Qin Z, Zhu Y, Shi DD, Chen R, Li S, Wu J. The gap between statistical and clinical significance: time to pay attention to clinical relevance in patient-reported outcome measures of insomnia. BMC Med Res Methodol. 2024 Aug 8;24(1):177. doi: 10.1186/s12874-024-02297-0.
PubMed 39118002Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009 Oct;25(10):2487-94. doi: 10.1185/03007990903167415.
PubMed 19689221
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Optimization With Acoustic Therapy: A Polysomnography-Based Pre-Post Study
- ClinicalTrials.gov ID
- NCT07503223
- Acronym / sponsor ID
- SONATA / FF-2026-126
- Conditions
- IMSOMNIA, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Personalized Sound TherapyAt baseline before intervention sleep study wil be performed along with assessment of Imsomnia Severity Index Scores, Pittsburgh Sleep Quality Index (PSQI), and Eppeorth Sleepiness Score |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18-60 years
- With sleep disturbances based on the PSQI score of >5 and/or ISI score > 15
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Sound TherapyParticipants 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 | Device | Treatment arm |
Primary outcome
Comparison in Sleep Architexture pre and post treatment
Time frame: 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.
5 secondary outcomes
Comparison of Imsonia Severity Index pre and post treatment
Time frame: 12 weeks
Comparison of Pittsburgh Sleep Quality Index (PSQI) pre and post treatment
Time frame: 12 weeks
Comparison of Epworth Sleepiness Scale (ESS) pre and post treatment
Time frame: 12 weeks
adverse events of the therapy
Time frame: 12 weeks
adherence of the treatment received
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 23185361Lustenberger C, Maric A, Durr R, Achermann P, Huber R. Triangular relationship between sleep spindle activity, general cognitive ability and the efficiency of declarative learning. PLoS One. 2012;7(11):e49561. doi: 10.1371/journal.pone.0049561. Epub 2012 Nov 21.
- Results publication: PubMed 20137989Baglioni C, Spiegelhalder K, Lombardo C, Riemann D. Sleep and emotions: a focus on insomnia. Sleep Med Rev. 2010 Aug;14(4):227-38. doi: 10.1016/j.smrv.2009.10.007. Epub 2010 Feb 6.
- Results publication: PubMed 9358396Perlis ML, Giles DE, Mendelson WB, Bootzin RR, Wyatt JK. Psychophysiological insomnia: the behavioural model and a neurocognitive perspective. J Sleep Res. 1997 Sep;6(3):179-88. doi: 10.1046/j.1365-2869.1997.00045.x.
- Results publication: PubMed 31071719Riemann D, Krone LB, Wulff K, Nissen C. Sleep, insomnia, and depression. Neuropsychopharmacology. 2020 Jan;45(1):74-89. doi: 10.1038/s41386-019-0411-y. Epub 2019 May 9.
- Results publication: PubMed 23583623Ngo HV, Martinetz T, Born J, Molle M. Auditory closed-loop stimulation of the sleep slow oscillation enhances memory. Neuron. 2013 May 8;78(3):545-53. doi: 10.1016/j.neuron.2013.03.006. Epub 2013 Apr 11.
- Results publication: PubMed 28364428Leminen MM, Virkkala J, Saure E, Paajanen T, Zee PC, Santostasi G, Hublin C, Muller K, Porkka-Heiskanen T, Huotilainen M, Paunio T. Enhanced Memory Consolidation Via Automatic Sound Stimulation During Non-REM Sleep. Sleep. 2017 Mar 1;40(3):zsx003. doi: 10.1093/sleep/zsx003.
- Results publication: PubMed 27318231Ong JL, Lo JC, Chee NI, Santostasi G, Paller KA, Zee PC, Chee MW. Effects of phase-locked acoustic stimulation during a nap on EEG spectra and declarative memory consolidation. Sleep Med. 2016 Apr;20:88-97. doi: 10.1016/j.sleep.2015.10.016. Epub 2015 Nov 27.
- Results publication: PubMed 32433768Arnal PJ, Thorey V, Debellemaniere E, Ballard ME, Bou Hernandez A, Guillot A, Jourde H, Harris M, Guillard M, Van Beers P, Chennaoui M, Sauvet F. The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging. Sleep. 2020 Nov 12;43(11):zsaa097. doi: 10.1093/sleep/zsaa097.
- Results publication: PubMed 40962569Aloulou A, Chauvineau M, Destexhe A, Leger D. Listening to the sound of your own brain waves enhances sleep quality and quantity. Sleep Med. 2025 Dec;136:106755. doi: 10.1016/j.sleep.2025.106755. Epub 2025 Aug 15.
- Results publication: PubMed 39118002Qin Z, Zhu Y, Shi DD, Chen R, Li S, Wu J. The gap between statistical and clinical significance: time to pay attention to clinical relevance in patient-reported outcome measures of insomnia. BMC Med Res Methodol. 2024 Aug 8;24(1):177. doi: 10.1186/s12874-024-02297-0.
- Results publication: PubMed 19689221Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009 Oct;25(10):2487-94. doi: 10.1185/03007990903167415.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Faisal Abdul Hamid, MBBS (IIUM) principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Sound Therapy in people with IMSOMNIA and Sleep Disturbance, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Faisal Abdul Hamid, MBBS (IIUM) (0391455555, faisal.hamid@hctm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison in Sleep Architexture pre and post treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503223, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.