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

NCT07106385 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-11

No results posted yet for this study

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

Interventions

DEVICE

rtms

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.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-04
Primary Completion
2027-06-27
Completion
2027-10-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106385 on ClinicalTrials.gov