CTRI/2026/01/102521尚未招募Unknown
Safety and Efficacy of Non-Invasive Treatment for Insomnia disorder.
BTL India Pvt Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月12日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Objectives:
Primary objective(s): The primary objective of the study is to demonstrate that BTL-699 is
safe and effective in treating the insomnia disorder.
Secondary objective(s):
1.To evaluate participants’ global sleep quality and daytime functioning
2.To evaluate participants’ satisfaction with the therapy.
3.To evaluate participants’ comfort with the therapy.
Type of the study:
Prospective, open-label, one-arm, single-center, interventional study.
Intended purpose of the investigational device:
The BTL-699 is intended for the treatment of insomnia disorder.
Intended population and indications for use:
The device is intended for adults only excluding pregnant or breastfeeding women. The
patient must not show any signs of contraindications. Before applying the therapy, it is
necessary to consider the patient’s medical history and examine the patient thoroughly to
determine whether or not the application of therapy is suitable for the patient. A special population where the safety and effectiveness of the therapy has not been established is
defined in the chapter Special population of the User’s manual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
Dr S Saravanan
Sagar Hospitals, Bengaluru
研究点 (1)
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