Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05715866 |
| Other study ID # |
ET_2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 7, 2021 |
| Est. completion date |
August 22, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Universidad de Murcia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
