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

Launched by BTL INDUSTRIES LTD. · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using a device called BTL-699-2 to see if it can help adults over the age of 22 sleep better and feel less stressed. The researchers want to find out if using this device improves sleep quality and reduces stress levels. To measure this, participants will answer several questionnaires about their sleep and stress before and after the treatments.

If you decide to join, you’ll receive six treatment sessions with the device. You’ll be asked to complete a few simple surveys about how well you sleep, how stressed you feel, and your comfort with the therapy. To be eligible, you must be over 22 years old and have some difficulty with sleep (as shown by a specific sleep quality score). You should not be using strong prescription sleep medications, and you must be able to avoid other sleep or stress treatments during the study. Certain health conditions—like having metal implants, a history of seizures, serious heart or kidney problems, or pregnancy—would prevent participation. The study is currently recruiting participants of all genders who meet these criteria and are willing to follow the study instructions and attend all visits.

Gender

ALL

Eligibility criteria

• 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