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

Safety and Efficacy of BTL-699-2 for the Improvement of Sleep Quality and Reduction of Stress

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

The study uses a multi-center, sham-controlled, single-blinded, interventional study design. The subjects will be enrolled and assigned to two experimental study arms - Group A and Group B in the ratio 3:1. Group A will receive active treatment and Group B, which received sham treatment, will serve as a control. All enrolled participants will receive six treatment visits, 3-7 days apart.

The Pittsburgh Sleep Quality Index, Perceived Stress Scale Questionnaire and Sleep and Stress Assessment Questionnaire will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits - 1 month and 3 months after the final session.

The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction will be given after the last treatment and at both follow-up visits.

The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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