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

BTL

Status

Enrolling

Conditions

Stress Reduction

Sleep Quality

Treatments

Device: Treatment with BTL-699-2 (sham)

Device: Treatment with BTL-699-2

Study type

Interventional

Funder types

Industry

Identifiers

NCT07027657

BTL-699_CTUS300

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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