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Comparative study efficacy of Thai massage (Nuad-Thai), Transcranial Magnetic Stimulation and Melatonin on People with Sleep Disorders (Randomized Controlled Trial)

Comparative study efficacy of Thai massage (Nuad-Thai), Transcranial Magnetic Stimulation, and Melatonin on People with Sleep Disorders (Randomized Controlled Trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251231006
Enrollment
45
Registered
2025-12-31
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disorders/insomnia symptoms Sleep Disorders Thai massage (NuadThai) Transcranial Magnetic Stimulation Melatonin

Interventions

Thai massage,Low frequency rTMS at 1 Hz delivered at 90 percentage of the individual RMT is known to produce an inhibitory effect on cortical excitability. The stimulation target was localized at the
Experimental Other,Experimental Other,Experimental Drug
Thai massage ,Transcraneal magnatic stimulation (TMS),Melatonin

Sponsors

National Research council of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 60 years. 2. Participants with a Pittsburgh Sleep Quality Index (PSQI) score of 6 or higher. 3. who have been clinically diagnosed by a physician with insomnia that interferes with daily functioning.

Exclusion criteria

Exclusion criteria: 1. Individuals with psychiatric disorders. 2. Individuals with neurological disorders. 3. Individuals who are pregnant or breastfeeding. 4. Individuals with hepatic and/or renal diseases. 5. Individuals with cardiovascular and/or heart diseases. 6. Individuals with implanted electronic devices, such as: 6.1 Programmable VP/LP shunts, 6.2 Cochlear implants, 6.3 Cortical or deep brain stimulators, 6.4 Spinal cord stimulators, or 6.5 Cardiac pacemakers. 7. Individuals with metallic implants in the body, such as: 7.1 Vascular stents, 7.2 Aneurysm clips, 7.3 Orthopedic fixation devices or joint prostheses, 7.4 Retained bullets, 7.5 Tattoos containing metallic pigments, or 7.6 Metallic threads used in cosmetic procedures. 8. Individuals at risk of seizures, including those with: 8.1 Epilepsy or uncontrolled seizure disorders, 8.2 Recent adjustment of antiepileptic medication within the past six months, 8.3 Large cortical lesions, 8.4 Chronic alcohol or substance abuse, or 8.5 Severe sleep deprivation. 9. Individuals with venous thrombosis, infected wounds, unhealed fractures, or cancer in the area to be stimulated by magnetic fields. 10. Individuals with known hypersensitivity to any components of melatonin, including: Ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, colloidal anhydrous silica, talc, and magnesium stearate. 11. Individuals who are currently receiving other treatments for sleep disorders.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index : PSQI at baseline and post-intervention 0-21; patient-reported questionnaire.,Insomnia Severity Index : ISI at baseline, during intervention 2 weeks and post-intervention 0-28; patient-reported questionnaire.,Electroencephalogram : EEG During the scheduled EEG recording session Standard EEG recording during sleep

Secondary

MeasureTime frame
Sleep Diary Daily throughout the duration of the study Daily self-reported sleep diary,36-Item Short Form Health Survey (SF-36) At baseline and post-intervention. 0-100 ; patient-reported questionnaire.,Pain Pressure Threshold At baseline and post-intervention. Measured using a pressure algometer.

Countries

Thailand

Contacts

Public ContactNongnuch Luangpon

Faculty of Allied Health Sciences, Burapha University

nongnuchl@go.buu.ac.th0845454463

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026