Neural correlates of Yoga Nidra for management of insomnia in peri-menopausal women
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- As the life expectancy is women is a few years longer than the men, to sustain healthy postmenopausal life which is about one third of their life (20-30 years), the technique of YogaNidra will help the participants to"
研究概览
简要总结
This clinical trial study involves using non-pharmacological therapeutic intervention of Yoga Nidra to address post-menopausal insomnia in achieving good quality sleep and to get control on emotional and cognitive states to improve overall well being in cozy home setup. We will also provide evidences for the mechanism of action of Yoga Nidra based on EEG, ECG parameter drive brain and autonomic states.
We will begin with questionnaire based screening of women in range of 45 to 65 years) using Sleep Health Index to have prevalence of insomnia in this age group. About 135 participants from Trivandrum zone will be selected for the objective measurement that will be based on actigraphy and EEG and ECG based assessment of health before Yoga or Yoga Nidra intervention of 24 weeks in insomniac postmenopausal women. We will be able to provide the neural correlates of Yoga Nidra to understand how this technique helps in improving the brain and thus well being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •In this trial, we propose to address postmenopausal insomnia in women by using Yoga Nidra as a non-pharmacological therapeutic tool in achieving good quality sleep and to get control on emotional and cognitive states for improving an overall wellbeing in a cozy home setup.
- •YogaNidra is a powerful technique known to reduce stress, anxiety and to attain self-control.
- •There are no randomized controlled trial studies (RCT) on Yoga Nidra to alleviate the insomnia associated with the menopausal changes in women.
- •Inclusion Criterion: In first part, a gross questionnaire (Sleep Health Index by National Sleep Foundation, US) based national survey will be undertaken for women above 45 years of age to 65 years without any criterion of health condition.
- •This will provide us a prevalence of insomnia in this age bracket.
- •In next step, Women in age group above 45 years undergoing or completed menopause only) will be selected through randomization process for intervention study in three groups.
- •One would be without Yoga, one with Yoga (protocol provided by NIMHANS for insomnia) and 3rd group in YogaNidra.
- •In each group, we will have objective measures in limited numbers of participants.
排除标准
- •Women with history of neuro-psychiatric diseases, hypertension, cardiovascular, diabetic, cancer or arthritis problems Women below 45 years and above 65 years.
结局指标
主要结局
As the life expectancy is women is a few years longer than the men, to sustain healthy postmenopausal life which is about one third of their life (20-30 years), the technique of YogaNidra will help the participants to"
时间窗: i. In first nine month, questionnaire based survey will be completed | 2. The recruitment of participants for objective measures (EEG based evaluation ) will start after CTRI registration, from May 2024. The pretreatment time is 4 weeks, and treatment with yoga is 24 weeks for which the EEG based assessment will be carried out at 4 weeks, 16 weeks and 24 weeks | 3. The Recruitment of participants for the subjective assessment will begin by June 2024
1. improve their sleep
时间窗: i. In first nine month, questionnaire based survey will be completed | 2. The recruitment of participants for objective measures (EEG based evaluation ) will start after CTRI registration, from May 2024. The pretreatment time is 4 weeks, and treatment with yoga is 24 weeks for which the EEG based assessment will be carried out at 4 weeks, 16 weeks and 24 weeks | 3. The Recruitment of participants for the subjective assessment will begin by June 2024
2. to improve quality of life and wellbeing.
时间窗: i. In first nine month, questionnaire based survey will be completed | 2. The recruitment of participants for objective measures (EEG based evaluation ) will start after CTRI registration, from May 2024. The pretreatment time is 4 weeks, and treatment with yoga is 24 weeks for which the EEG based assessment will be carried out at 4 weeks, 16 weeks and 24 weeks | 3. The Recruitment of participants for the subjective assessment will begin by June 2024
3. To provide evidences on mechanism of action of YogaNidra through objective measures
时间窗: i. In first nine month, questionnaire based survey will be completed | 2. The recruitment of participants for objective measures (EEG based evaluation ) will start after CTRI registration, from May 2024. The pretreatment time is 4 weeks, and treatment with yoga is 24 weeks for which the EEG based assessment will be carried out at 4 weeks, 16 weeks and 24 weeks | 3. The Recruitment of participants for the subjective assessment will begin by June 2024
4. To increase productivity at home and social networks through their experience of life.
时间窗: i. In first nine month, questionnaire based survey will be completed | 2. The recruitment of participants for objective measures (EEG based evaluation ) will start after CTRI registration, from May 2024. The pretreatment time is 4 weeks, and treatment with yoga is 24 weeks for which the EEG based assessment will be carried out at 4 weeks, 16 weeks and 24 weeks | 3. The Recruitment of participants for the subjective assessment will begin by June 2024
次要结局
- Secondary outcomes will be related physical health(6 months)
研究者
Kamalesh K Gulia
Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum