Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Preliminary evidence of efficacy
研究概览
简要总结
Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment.
This pilot clinical trial is testing whether a device called VeNS (vestibular nerve stimulation) can safely and effectively improve sleep in adults who are visually impaired.
The study will compare the active VeNS device to a sham (inactive) device. Participants will use the device under supervision for 30 minutes a day over 4 weeks, followed by a 4-week observation period. Researchers will assess sleep improvements, safety, and how acceptable and easy the treatment is for participants.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study
Intervention Model: Parallel Assignment in 1:1 active to control allocation
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 8 weeks in total for each subject.
详细描述
Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment.
Type of trial: A Pilot Randomized, Double-blind Sham-controlled Clinical Trial. Aim of the study: The aim of this pilot clinical trial is to evaluate the feasibility, safety and preliminary efficacy of VeNS compared to a Sham for improving sleep in individuals who are visually impaired.
For this aim the clinical trial will evaluate the study retention rate, completion rate, adherence to the treatment regimen, and user experience questionnaire for acceptability measures (barriers, facilitators, participant burden, reasons for dropping out, satisfaction, perceptions).
The study duration will be of 8 weeks with 4 weeks intervention and 4 weeks follow up. To determine the preliminary efficacy the study will measure the change in ISI from baseline to week 4 (Primary Outcome) and the Change in PSQI score and SF-36 (physical and mental component scores) from baseline to week 4 (Secondary Outcome). Safety will be evaluated by assessing the frequency and severity of adverse events (AEs) reported during the 4-week treatment period and the proportion of participants experiencing serious adverse events (SAEs) reported during the 4-week treatment period.
Researchers will compare the real VeNS device to a sham device that looks the same but delivers no stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Male or female, age ≥ 20 years and ≤ 60 years at the time of signing informed consent
- •PSQI score ≥ 5 at screening and baseline
- •Symptoms of sleep disorder lasting ≥ 3 months at the time of screening
- •Severely Sight Impaired (defined as a visual acuity of < 6/60 but ≥3/60 at 6 meters) OR blind (defined as a visual acuity of <3/60 at 6 metres).
- •Participants must be accompanied by a family member or carer during the enrollment and initial study visit. For subsequent visits, accompaniment is encouraged; if a companion is unavailable, assistance will be provided by study staff or trained personnel.
- •Can speak/read Hindi or English
- •Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol
- •Ability and willingness to attend the clinic for 30-minute stimulation sessions 5 days per week for the duration of the treatment period (4-weeks).
- •Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
- •Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial and haven't for 4 weeks before the trial
- •Agreement not to use sleep trackers for the duration of the study (e.g. sleep app smart watches such as Fitbits)
- •Agree not to travel across multiple time-zones during the duration of the study
- •Agree to maintain a familiar sleeping environment/routine throughout the study and will not discontinue or begin treatment with new devices, used while sleeping, during the study (e.g. CPAP machines)
排除标准
- •A PSQI score < 5 at screening
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- •Previous diagnosis of a chronic viral infection, for example hepatitis or HIV
- •A history of stroke or severe head injury requiring intensive care or neurosurgery
- •Diagnosis of a current psychotic disorder
- •Suffering from a current characterized depressive episode
- •Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
- •Pregnancy or breast-feeding or intends to become pregnant
- •History of epilepsy
- •History of active migraines with aura
- •History of head injury requiring intensive care or neurosurgery
- •History of diagnosed cognitive impairment such as Alzheimer's disease/dementia
- •History of bipolar, psychotic or substance use disorders
- •Regular use (more than twice a month) of antihistamine medication within the last 6 month. The subject can opt to switch to Fexofenadine (non-drowsy) and may enroll after a wash-out period of 2 weeks.
- •History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- •A diagnosis of myelofibrosis or a myelodysplastic syndrome.
- •Previous use of any VeNS device
- •Participation in other clinical trials sponsored by Neurovalens or other insomnia studies
- •Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
- •History of vestibular dysfunction or other inner ear disease
- •Member of the same household is currently or has previously participated in clinical study sponsored by Neurovalens
研究组 & 干预措施
Active VeNS Device
The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will use the device under supervision at the clinical site for 30 minutes per day.
干预措施: Intervention (VeNS Stimulation) Device (Device)
Sham Device
The sham device looks identical to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will use the device under supervision at the clinical site for 30 minutes per day.
干预措施: Control (Sham Stimulation) Device (Device)
结局指标
主要结局
Preliminary evidence of efficacy
时间窗: 4 weeks
Change in Insomnia Severity Index (ISI) from baseline to week 4.
Safety Outcome
时间窗: 4 weeks
Assess the frequency and severity of adverse events (AEs) reported during the 4-week treatment period. Assess the proportion of participants experiencing serious adverse events (SAEs) reported during the 4-week treatment period.
次要结局
- Change in PSQI score from baseline to week 4.(4 weeks)
- Change in SF-36 from baseline to week 4.(4 weeks)