The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness

NCT07106385 | Recruiting

• 1 other identifier: UW 25-281
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness Introduction The investigators would like to invite participants to participate in a study on the efficacy of using magnetic fields to improve sleep quality in adults with no serious mental illness. The research leader is Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Queen Mary Hospital/ HKU Li Ka Shing Faculty of Medicine. Please read the following information carefully. If necessary, participants can discuss with relatives, friends or doctors. If anything is unclear, or if participants would like more information, please ask us. Please carefully consider whether participants are willing to participate in this research. Research Purpose Sleep is a fundamental component of overall health and well-being, playing a crucial role in cognitive function, emotional regulation, and physical health. However, sleep complaints are common, even among otherwise healthy adults, often leading to reduced quality of life and increased health risks. The prevalence of poor sleep quality can be attributed to a variety of factors, including stress, lifestyle habits, and environmental disturbances. rTMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity in targeted brain regions. Over the years, rTMS has shown promise in treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD) and clinical insomnia. Research Methods Participants Healthy adults aged 18-65 with self-reported sleep complaints. Treatment protocol Six sessions of rTMS using the EXOMIND™ device, administered once or twice a week. Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds. The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in the research centre with medical staff supported. A checklist of potential adverse effects from TMS administration will be referenced from existing literature to monitor tolerability and adverse events during each session. Blood pressure and heart rate will be recorded at the beginning and end of each session. Assessment Participants will be assessed at three time points: baseline (pre-intervention), post-intervention, and four weeks post-intervention. Assessments: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Patient Health Questionnaire-9 (PHQ-9), and home sleep monitoring device. Demographics: age, gender, years of education, place of birth, marital status, number of children, financial condition, household income, family history of sleep difficulties will be collected upon study entry. Medical history in relation to mental illnesses and medications will also be assessed.

Conditions

Rtms; Sleep

Keywords

rtms; sleep; health adults

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  Using Pittsburgh Sleep Quality Index (PSQI) to measure subjective sleep quality In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention

Secondary Outcomes (3)

• Perceived Stress Scale (PSS)

  Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention

• Sleep time and stages

  Baseline: 7 consecutive nights before the rTMS intervention starts Post-intervention: 7 consecutive nights after the last session rTMS intervention

Study Arms (1)

healthy adults

EXPERIMENTAL

Device: rtms

Interventions

rtms DEVICE

Participants will undergo a treatment protocol involving six sessions of rTMS using the EXOMIND™ device, administered once or twice a week. Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds. The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in our research centre with medical staff supported.

healthy adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Aged between 18-65
• Self-reported sleep complaints

You may not qualify if:

• Serious mental illness other than primary insomnia
• Severe neurological conditions
• Contraindications for rTMS.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, HKU

Hong Kong, Pok Fu Lam, Hong Kong

RECRUITING

Related Publications (6)

• Voineskos D, Blumberger DM, Rogasch NC, Zomorrodi R, Farzan F, Foussias G, Rajji TK, Daskalakis ZJ. Neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) in treatment resistant depression. Clin Neurophysiol. 2021 Sep;132(9):2306-2316. doi: 10.1016/j.clinph.2021.05.008. Epub 2021 Jun 1.

  PMID: 34167891 BACKGROUND

• Sabe M, Hyde J, Cramer C, Eberhard A, Crippa A, Brunoni AR, Aleman A, Kaiser S, Baldwin DS, Garner M, Sentissi O, Fiedorowicz JG, Brandt V, Cortese S, Solmi M. Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation Across Mental Disorders: A Systematic Review and Dose-Response Meta-Analysis. JAMA Netw Open. 2024 May 1;7(5):e2412616. doi: 10.1001/jamanetworkopen.2024.12616.

  PMID: 38776083 BACKGROUND

• Liang K, Li H, Bu X, Li X, Cao L, Liu J, Gao Y, Li B, Qiu C, Bao W, Zhang S, Hu X, Xing H, Gong Q, Huang X. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. 2021 May 28;11(1):332. doi: 10.1038/s41398-021-01453-0.

  PMID: 34050130 BACKGROUND

• Zhu L, Dang G, Wu W, Zhou J, Shi X, Su X, Ren H, Pei Z, Lan X, Lian C, Xie P, Guo Y. Functional connectivity changes are correlated with sleep improvement in chronic insomnia patients after rTMS treatment. Front Neurosci. 2023 Apr 17;17:1135995. doi: 10.3389/fnins.2023.1135995. eCollection 2023.

  PMID: 37139515 BACKGROUND

• Ma H, Lin J, He J, Lo DHT, Tsang HWH. Effectiveness of TES and rTMS for the Treatment of Insomnia: Meta-Analysis and Meta-Regression of Randomized Sham-Controlled Trials. Front Psychiatry. 2021 Oct 22;12:744475. doi: 10.3389/fpsyt.2021.744475. eCollection 2021.

  PMID: 34744835 BACKGROUND

• Sun N, He Y, Wang Z, Zou W, Liu X. The effect of repetitive transcranial magnetic stimulation for insomnia: a systematic review and meta-analysis. Sleep Med. 2021 Jan;77:226-237. doi: 10.1016/j.sleep.2020.05.020. Epub 2020 May 22.

  PMID: 32830052 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Pak Wing Cheng

CONTACT

85290169487; chengpsy@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): June 27, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)