EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Quality, Stress Reduction

In brief

The goal of this clinical trial is to evaluate whether the treatment with BTL-699-2 device is able to improve sleep quality and reduce stress in adults above the age of 22 years. The main questions it aims to answer are: Does the treatment with BTL-699-2 device improve sleep quality? Does the treatment with BTL-699-2 device reduce stress? Participants will be asked to: * Undergo six treatments * Complete the Pittsburgh Sleep Quality Index * Complete the Perceived Stress Scale Questionnaire * Complete the Sleep and Stress Assessment Questionnaire * Complete the Therapy Comfort and Subject Satisfaction Questionnaire

Key facts

Study ID: NCT07027657
Run by: BTL Industries Ltd.
People needed: 43
Starts: 2025-05-02
Expected to finish: 2025-11-11
Last updated by the study team: 2026-03-30

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age > 22 years
The minimal pre-treatment PSQI score of >= 5 points
Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in sleep quality and reduction of stress, including non-invasive brain stimulation treatments other than the study procedure during study participation
Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
Willingness to comply with study instructions and to return to the clinic for the required visits
Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry
Subject is not using any sleeping medication or is using over-the-counter pills (except Valerian and St. John's Wort) no more than 4 times a week

You may not qualify if…

Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators
Metallic, ferromagnetic or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 in (30 cm) of the therapy coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes and tattoos with metallic ink),
Drug pumps (within 12 in (30 cm) of the therapy coil)
Application in the heart area
Persons with a tendency to seizure (hypotonic, epileptic)
Ongoing anticoagulation therapy
Ongoing severe or life-threatening condition
Pulmonary insufficiency
Heart disorders
Renal insufficiency
Decompensated* hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
Malignant tumor, benign tumor
Fever
Ongoing pregnancy
Suicidal tendencies or recent attempt to commit suicide
Concurrent use of electroconvulsive therapy or vagus nerve stimulation
Substance-induced depression or depression secondary to a general medical condition
Seasonal affective disorder
Substance abuse, obsessive compulsive disorder or post-traumatic stress disorder, major depression
Psychotic disorder including schizoaffective disorder, bipolar disease or major depression with psychotic features
Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia or movement disorders
History of increased intracranial pressure or head trauma
Nursing
Usage of prescription sleep medication, Valerian of St. John's Wort in the past 2 months
Usage of over-the-counter pills 5 or more times a week

Where it is running

AntiAging and Wellness — Chula Vista, California, United States
Kind Health Group — Encinitas, California, United States
Minooka Healthcare Center — Minooka, Illinois, United States

Full record on ClinicalTrials.gov

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