RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05-02

Study Completion:2026-08-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07027657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

AntiAging and Wellness

Chula Vista, California, 91914

United States

Kind Health Group

Encinitas, California, 92024

United States

Minooka Healthcare Center

Minooka, Illinois, 60447

United States

Collaborators and Investigators

Sponsor: BTL Industries Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-02

Study Completion Date2026-08-02

Study Record Updates

Study Start Date2025-05-02

Study Completion Date2026-08-02

Terms related to this study

Keywords Provided by Researchers

rTMS
TMS
Sleep Quality
Stress Reduction

Additional Relevant MeSH Terms

Sleep Quality
Stress Reduction