Health Condition 1: G47- Sleep disorders
Conditions
Interventions
Intervention1: BTL-699, applicator BTL-699-AP-M-2
: The device is intended for the treatment of insomnia disorder.
The treatment administration phase will consist of six treatment visits spaced 2 7 d
Sponsors
BTL India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Adult subjects aged 18 and older seeking treatment for insomnia disorder -Sleep difficulties at least 3 nights per week -Sleep difficulties have persisted for more than 3 months -Subjects meet DSM-5 criteria for Insomnia Disorder 1.Predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms -difficulty initiating sleep. -difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakening. -Early-morning awakening with inability to return to sleep. 2.The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. 3.The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder such as narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, or a parasomnia. 4.Coexisting mental disorders and mental conditions do not adequately explain the predominant complaint of insomnia. 5.The insomnia is not attributable to the physiological effects of a substance, such as a drug of abuse or a medication. -At least 15 points in Insomnia Severity Index (ISI) -Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form. -Subjects are willing and able to comply with protocol requirements, including obtaining study-required assessments and returning for follow-up visits -Subjects willing and able to abstain from partaking in any treatments other than the study procedure (including prescribed or over-the-counter sleeping medication) to treat insomnia disorder during study participation -Subjects are willing not to travel to different time zones and to maintain a familiar sleeping routine -Women of childbearing potential are required to use birth control measures.
Exclusion criteria
Exclusion criteria: Any subject who is meeting any of the following criteria will be excluded from participation in the study 1.Electronic implants -implanted stimulator devices in or near the head; rTMS devices are contraindicated for use in patients who have active or inactive implants, including device leads, deep brain stimulators, cochlear implants, ocular implants -and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators or other electronic implants in or near the head 2.Metallic, ferromagnetic or other magnetic-sensitive implants or 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 the Safety Precautions and Warnings or within 30 cm (12 in) of the treatment coil (examples include implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery, and hair barrettes) 3.Application in the heart area 4.Persons with a tendency to seizures (e.g. persons suffering from hypotonia and epilepsy) 5.Anticoagulation therapy 6.Severe or life-threatening condition 7.Renal dialysis therapy or decompensated renal insufficiency 8.Decompensated hemorrhagic conditions 9.Decompensated blood coagulation disorders 10.Decompensated cardiovascular diseases 11.Malignant tumor or benign tumor (within 30 cm of the treatment coil) 12.Fever 13.Application over or in the near proximity (within 30 cm of the treatment coil) of tattoos with metallic ink 14.Suicidal tendencies or recent suicide attempt 15.Varying degrees of medication resistance 16.Concurrent use of electroconvulsive therapy or vagus nerve stimulation 17.Ongoing or recent changes (less than 30 days) in intake doses of any pharmaceutical products, standalone or in combination, that might lower the threshold of seizure potential 18.Ongoing withdrawal conditions from any dependence substance or medication associated with an altered seizure risk history 19.A psychotic disorder, including schizoaffective disorder, bipolar disease, or major depression with psychotic features 20.History of primary or secondary tumors in the CNS, cerebral aneurysm 21.History of increased intracranial pressure or head trauma with loss of consciousness 22.Ongoing pregnancy or breastfeeding 23.Presence of other sleep disorders (as evaluated by specific questions from structured interview)e.g.sleep apnea, periodic leg movements while sleeping, or parasomnias) 24.Presence of clinically significant psychiatric disorders,e.g. schizophrenic and affective psychotic spectrum disorders, organic brain diseases with psychotic symptoms, post-traumatic stress disorder, addictions. 25.Any other disease or condition at the investigator discretion that may pose a risk to the patient or compromise the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change (decrease) in Insomnia Severity Index (ISI) score at the 30-day follow-up greater than 6 points when compared to the baseline value. Timepoint: At the baseline visit, before the first study treatment, subjects will be examined to confirm inclusion and exclusioncriteria. Upon verification of the inclusion/exclusion criteria, the subjects will be required tocomplete six treatments spaced 2 7 days apart and one follow-up visit 30 days after the lasttreatment. The approximate subject participation duration is 3 months after the enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The change (decrease) in Pittsburgh Sleep quality index (PSQI) total score from baseline to the 30-day follow-up assessment. 2.At least 80 percent of the treated subjects to report satisfaction (level satisfied or very satisfied) with the therapy outcome at 30-day follow-up using the Subject Satisfaction Questionnaire. 3.Evaluation of the therapy comfort during the therapy with BTL-699 device via the Therapy comfort questionnaire. Timepoint: At the baseline visit, before the first study treatment, subjects will be examined to confirm inclusion and exclusion criteria. Upon verification of the inclusion/exclusion criteria, the subjects will be required to complete six treatments spaced 2 7 days apart and one follow-up visit 30 days after the last treatment. The approximate subject participation duration is 3 months after the enrollment. | — |
Countries
India
Contacts
Public ContactDr S Saravanan
Sagar Hospitals, Bengaluru
Outcome results
None listed