Personalized acoustic therapy to improve sleep for adults with insomnia.
Sleep Optimization With Acoustic Therapy: A Polysomnography-Based Pre-Post Study
This study will test whether nightly personalized sound-frequency therapy can improve sleep architecture and sleep quality in adults with insomnia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT07503223 on ClinicalTrials.gov |
What this trial studies
This single-arm, prospective pre-post interventional study will deliver nightly personalized sound-frequency therapy to adults with insomnia for 12 weeks. Full-night polysomnography is performed at baseline and after 12 weeks to measure changes in sleep stages, total sleep time, sleep latency, and sleep efficiency. Secondary outcomes include PSQI, ISI, AHI, ESS, and measures of adherence, tolerability, and acceptability. Participants are recruited from patients and hospital staff at Hospital Canselor Tuanku Muhriz UKM in Kuala Lumpur.
Who should consider this trial
Good fit: Adults aged 18–60 with insomnia symptoms (PSQI >5 and/or ISI >15) who can attend in-person polysomnography visits and meet eligibility criteria are the intended candidates.
Not a fit: People with moderate-to-severe obstructive sleep apnea (AHI >15), significant hearing loss, epilepsy, current use of sedative-hypnotics or neurostimulation devices, psychiatric disorders, shift work, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the therapy could improve objective sleep stages and subjective sleep quality without adding sedative medications.
How similar studies have performed: Previous small studies of auditory stimulation have shown increases in slow-wave activity and some sleep benefits, but personalized nocturnal sound-frequency therapy for insomnia is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cheras, Kuala Lumpur
- National University of Malaysia, Faculty of Medicine — Cheras, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Mohamed Faisal Abdul Hamid, MBBS (IIUM) — National University of Malaysia
- Study coordinator: Mohamed Faisal Abdul Hamid, MBBS (IIUM)
- Email: faisal.hamid@hctm.ukm.edu.my
- Phone: 0391455555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.