About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy adults
Aged between 18-65
Self-reported sleep complaints
Disqualifiers
Serious mental illness other than primary insomnia
Severe neurological conditions
Contraindications for rTMS.
Trial design
Single group
Treatments tested in this trial
rtms
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Perceived Stress Scale (PSS)
Using perceived stress scale (PSS) to evaluate perceived stress levels. First, reverse the scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. * Now add up the scores for each item to get a total. The total score is \_\_\_\_\_\_\_\_\_\_\_. * Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress
Patient Health Questionnaire-9 (PHQ-9)
Using Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms Scoring: add up all checked boxes on PHQ-9 (For every 3 Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3) Interpretation of Total Score: Total Score Depression Severity 1-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Sleep time and stages
Using sleep watch to measure total sleep time and duration of each sleep stage (in minutes). Participants are required to wear a watch when they sleep to monitor their sleep time and duration of each sleep stage. This is to provide an objective data in pre- and post intervention changes.
Sponsors and contacts
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