Personalized acoustic therapy to improve sleep for adults with insomnia.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.