The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness
Phase: NA
Conditions: Rtms, Sleep
Sponsor: The University of Hong Kong

 
rTMS_sleep quality_25062025 protocol (v3) 
The effectiveness of repetitive transcranial magnetic stimulation (rTMS) on 
improving sleep quality in adults without serious mental illness 
Repetitive Transcranial Magnetic Stimulation (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 depression1,2, obsessive-compulsive disorder (OCD)3,4 
and clinical insomnia5,6,7. 
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. 
Prior research on rTMS and sleep has primarily focused on clinical populations, 
particularly individuals with insomnia or sleep disorders comorbid with other health 
conditions. While these studies have provided valuable insights, there is a 
burgeoning interest in exploring the effects of rTMS on sleep quality in the general 
population, specifically targeting those who report sleep complaints but do not meet 
the criteria for clinical insomnia. 
This research proposal aims to investigate the effects of rTMS on sleep quality 
among healthy adults experiencing subclinical sleep issues. By focusing on this 
population, we hope to uncover the potential of rTMS as a preventive intervention, 
offering individuals a non-pharmacological option to enhance sleep without the side 
effects often associated with sleep medications. 
Understanding the impact of rTMS on sleep in this demographic could pave the way 
for larger-scale studies and clinical applications, ultimately contributing to better 
sleep hygiene and enhanced quality of life for those affected by sleep complaints. 
 
 

 
rTMS_sleep quality_25062025 protocol (v3) 
Methodology 
Study Design 
This open-label pilot study aims to evaluate the effectiveness of repetitive 
transcranial magnetic stimulation (rTMS) in improving sleep quality among healthy 
adults with sleep complaints.  
An existing literature studying the effects of rTMS on sleep quality and mood in 
patients with major depressive disorder with similar outcome measures, has sample 
size of 21. Thus, this study will enrol 30 participants who meet the inclusion criteria. 
Participants 
30 participants will be recruited from the community through advertisement including 
universities based on the following criteria: 
- 
Healthy adults aged 18-65 
- 
self-reported sleep complaints 
Exclusion criteria include serious mental illness other than primary insomnia, severe 
neurological conditions, and contraindications for rTMS. 
Hypothesis  
rTMS significantly improves sleep quality among healthy adults experiencing 
subclinical sleep issues. 
Intervention setting 
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. 
Baseline Assessments  
    
The subjects’ basic demographic data, including 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. 
 
Outcome Measures 
Assessments will be conducted at three time points: baseline (pre-intervention), 
post-intervention, and four weeks post-intervention. 
Primary Outcome 
 Pittsburgh Sleep Quality Index (PSQI): Measures overall sleep quality. 

 
rTMS_sleep quality_25062025 protocol (v3) 
Secondary Outcomes 
- 
Perceived Stress Scale (PSS): Evaluates perceived stress levels. 
- 
Patient Health Questionnaire-9 (PHQ-9): Assesses depressive symptoms. 
- 
Home sleep monitoring: Collects data on sleep duration and sleep stages. 
Adverse effects 
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. 
Statistical Analysis 
Data will be analysed using SPSS version 26.0 or a similar statistical software 
package. 
All the descriptive data including the age and educations will calculate means and 
standard deviations for continuous variables and frequencies and percentages for 
categorical variables. Repeated measures ANOVA will be used to assess changes in 
PSQI scores across the three time points (baseline, post-intervention, and 4 weeks 
post-intervention). Paired t-tests will be conducted to evaluate changes in PSS and 
PHQ-9 scores, as well as sleep duration and sleep stages recorded by the Apple 
Watch, between baseline and post-intervention, and between baseline and 4 weeks 
post-intervention. A p-value of <0.05 will be considered statistically significant. 
Impact of the study 
This study contributes to the growing body of literature on non-pharmacological 
interventions for sleep improvement. By focusing on a non-clinical population, it 
expands the understanding of how rTMS can benefit individuals experiencing 
everyday sleep disturbances. Results could pave the way for integrating rTMS as a 
preventive intervention in clinical practice, offering an alternative to traditional sleep 
medications. This could be particularly beneficial for individuals who are sensitive to 
medication side effects or those who prefer non-drug therapies. As a pilot study, this 
research sets the groundwork for larger, more comprehensive trials. Positive findings 
could lead to further exploration of rTMS applications across different populations 
and settings, encouraging innovation in sleep disorder treatments. 
Handling and storage of personal data and study data 
Personal data will be anonymized and kept in password protected computers during 
and after the study; raw data will be anonymized and kept in locked rooms. Only 
principal investigator and authorized research assistants will have access to and are 
responsible for safekeeping of the stored data. 
Personal data will be kept for 5 years after completion of study and publications to 
keep track on potential side effects related to the intervention, and will be destroyed 
after completion of publications. 

 
rTMS_sleep quality_25062025 protocol (v3) 
Compliance with the ICH-GCP 
This study complies with ICH-GCP. 
Compliance with Declaration of Helsinki 
It declares that the research was conducted according to ethical standards, 
including the Declaration of Helsinki and its amendments. 
Funding  
This research received no specific grant from any funding agency in the public, 
commercial, or not-for-profit sectors. 
Conflict of Interest Statement  
 
There are no conflicts of interest regarding the use of the rTMS machine in this study 
that influenced the design, implementation, or interpretation of the research. 
 
 

 
rTMS_sleep quality_25062025 protocol (v3) 
References 
1. Sabé, Michel, et al. "Transcranial magnetic stimulation and transcranial direct 
current stimulation across mental disorders: a systematic review and dose-
response meta-analysis." JAMA network Open 7.5 (2024): e2412616-
e2412616. 
2. Voineskos, Daphne, et al. "Neurophysiological effects of repetitive transcranial 
magnetic stimulation (rTMS) in treatment resistant depression." Clinical 
Neurophysiology 132.9 (2021): 2306-2316. 
3. Fitzsimmons, Sophie MDD, et al. "Repetitive transcranial magnetic stimulation 
for obsessive-compulsive disorder: A systematic review and pairwise/network 
meta-analysis." Journal of affective disorders 302 (2022): 302-312. 
4. Liang, Kaili, et al. "Efficacy and tolerability of repetitive transcranial magnetic 
stimulation for the treatment of obsessive-compulsive disorder in adults: a 
systematic review and network meta-analysis." Translational psychiatry 11.1 
(2021): 332. 
5. Zhu, Lin, et al. "Functional connectivity changes are correlated with sleep 
improvement in chronic insomnia patients after rTMS treatment." Frontiers in 
Neuroscience 17 (2023): 1135995. 
6. Ma, Haixia, et al. "Effectiveness of TES and rTMS for the treatment of 
insomnia: meta-analysis and meta-regression of randomized sham-controlled 
trials." Frontiers in psychiatry 12 (2021): 744475. 
7. Sun, Nianyi, et al. "The effect of repetitive transcranial magnetic stimulation 
for insomnia: a systematic review and meta-analysis." Sleep Medicine 77 
(2021): 226-237.