Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 8:07 PM
Study NCT ID:
NCT05715866
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Stimulation Through Nesa and Therapeutic Exercise on Sleep Disturbances on Alzheimer's Disease Patients.
Sponsor:
Universidad de Murcia
Organization:
Study Overview
Official Title:
Effect of Non-invasive Stimulation Through Nesa and Therapeutic Exercise on Sleep Disturbances on Alzheimer's Disease Patients. Randomized Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to know the effectiveness of an adapted therapeutic exercise program and its comparison with non-invasive neuromodulation through the NESA device, and both treatments with a control group, to improve sleep disturbances and cognitive function in patients with dementia, and improves the quality of life of their caregivers.
Detailed Description:
Sleep disorders affect 30% of patients with dementia, being a very frequent symptom and appearing above all in the more advanced phases, and contribute to the risk of greater institutionalization, overload, and poorer quality of life for caregivers and abuse of sleep psychoactive drugs. Sleep disturbance is frequent in dementia, appearing especially in the more advanced stages. Non-pharmacological treatments are emerging as procedures of first choice to improve night rest in patients with Alzheimer's disease, however, given that the drugs do not remove the amyloid deposits that are formed or prevent their formation, and they have side effects adverse effects, the need arises to look for other options to improve the functioning of neuronal plasticity.
In Alzheimer's disease, therapeutic exercise has preventive and delayed effects against cognitive deterioration, in addition, it has been associated with changes in the circadian rhythm phases, however, there are no published controlled studies that analyze the isolated effects of exercise on sleep disturbances in patients with dementia.
Likewise, non-invasive neuromodulation through the NESA device consists of an alteration of the nervous activity through the delivery of microcurrents, which leads to a series of neuromodulated responses of the ANS neural cascades that gives rise to variations in the responses. endogenous of those dysfunctional or pathological bioelectrical systems.
Stimulation of the pineal gland through its sympathetic innervation results in the production of melatonin, a synchronizer of the circadian rhythm. In dementia there is a decrease in the level of melatonin, with non-invasive neuromodulation the pineal gland could be stimulated through its sympathetic innervation, resulting in the production of melatonin.
Objective: To know the effectiveness of an adapted therapeutic exercise program and its comparison with non-invasive neuromodulation through the NESA device, and both treatments with a control group, to improve sleep disturbances and cognitive function in patients with dementia. and improves the quality of life of their caregivers.
Methodology: This is a multicenter randomized clinical trial, with 30 patients diagnosed with dementia from two associations in the Region of Murcia for patients with Alzheimer's disease and other dementias, divided into three treatment groups, one of whom will receive non-invasive neuromodulation through NESA, another will be treated with therapeutic exercise, and a third control group, whose relatives will be given a brochure with sleep hygiene measures at the beginning of the study. The treatment will last 2 months for the neuromodulation group and 5 months for the therapeutic exercise group.
The measurements of the results are made individually, and under the same conditions for all the patients. These focus on cognitive and sleep variables for the patient with dementia and psychosocial variables to measure the quality of life of the caregiver. Each patient will be evaluated in four moments:
1. The first assessment before beginning the intervention period (pre-treatment)
2. The second evaluation in the middle of the treatment.
3. The third assessment at the end of the intervention period. (post-treatment)
4. The fourth two months after finishing the intervention. (tracing) The evaluators are masked. To measure the sleep variable, we have used various scales that reveal data on quality, efficiency, and quantity: Pittsburg sleep quality index (PSQI) and test de Epworth. To measure the cognitive variable for the patient with dementia, a scale has been used: Mini-Cognitive Exam Test (MEC). To measure the quality-of-life variable for the caregiver of the patient with dementia, the following scales have been used: Zarit scale and visual analogue scale (EVA).
In Alzheimer's disease, therapeutic exercise has preventive and delayed effects against cognitive deterioration, in addition, it has been associated with changes in the circadian rhythm phases, however, there are no published controlled studies that analyze the isolated effects of exercise on sleep disturbances in patients with dementia.
Likewise, non-invasive neuromodulation through the NESA device consists of an alteration of the nervous activity through the delivery of microcurrents, which leads to a series of neuromodulated responses of the ANS neural cascades that gives rise to variations in the responses. endogenous of those dysfunctional or pathological bioelectrical systems.
Stimulation of the pineal gland through its sympathetic innervation results in the production of melatonin, a synchronizer of the circadian rhythm. In dementia there is a decrease in the level of melatonin, with non-invasive neuromodulation the pineal gland could be stimulated through its sympathetic innervation, resulting in the production of melatonin.
Objective: To know the effectiveness of an adapted therapeutic exercise program and its comparison with non-invasive neuromodulation through the NESA device, and both treatments with a control group, to improve sleep disturbances and cognitive function in patients with dementia. and improves the quality of life of their caregivers.
Methodology: This is a multicenter randomized clinical trial, with 30 patients diagnosed with dementia from two associations in the Region of Murcia for patients with Alzheimer's disease and other dementias, divided into three treatment groups, one of whom will receive non-invasive neuromodulation through NESA, another will be treated with therapeutic exercise, and a third control group, whose relatives will be given a brochure with sleep hygiene measures at the beginning of the study. The treatment will last 2 months for the neuromodulation group and 5 months for the therapeutic exercise group.
The measurements of the results are made individually, and under the same conditions for all the patients. These focus on cognitive and sleep variables for the patient with dementia and psychosocial variables to measure the quality of life of the caregiver. Each patient will be evaluated in four moments:
1. The first assessment before beginning the intervention period (pre-treatment)
2. The second evaluation in the middle of the treatment.
3. The third assessment at the end of the intervention period. (post-treatment)
4. The fourth two months after finishing the intervention. (tracing) The evaluators are masked. To measure the sleep variable, we have used various scales that reveal data on quality, efficiency, and quantity: Pittsburg sleep quality index (PSQI) and test de Epworth. To measure the cognitive variable for the patient with dementia, a scale has been used: Mini-Cognitive Exam Test (MEC). To measure the quality-of-life variable for the caregiver of the patient with dementia, the following scales have been used: Zarit scale and visual analogue scale (EVA).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: