Clinical trial NCT05715866: Non-invasive Stimulation Through Nesa and Therapeutic Exercise on Sleep Disturbances on Alzheimer's Disease Patients.
Official title: Effect of Non-invasive Stimulation Through Nesa and Therapeutic Exercise on Sleep Disturbances on Alzheimer's Disease Patients. Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
sleep disorders
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random intervention model
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* obtaining a medical diagnosis of dementia equal to or greater than mild according to the Reisberg Global Deterioration Scale (GDS)
* having stable medical and pharmacological conditions, as well as their ability to perform physical activity and follow instructions verbal

Exclusion Criteria:

* wearing a pacemaker
* presenting internal bleeding
* skin with ulcerations
* acute febrile processes
* diagnosis of cancer
* phobia of electricity
* comorbidity that affects the sleep

Primary outcomes:
measure: Change in sleep quality
timeFrame: [Time frame: Measurement of change: before treatment (baseline), at two months (mid-treatment), at five months (end of treatment), and at 7 months of treatment (follow-up period)
measure: Change in cognitive status
timeFrame: [Time frame: Measurement of change: before treatment (baseline), at two months (mid-treatment), at five months (end of treatment), and at 7 months of treatment (follow-up period)
measure: Change in quality of life
timeFrame: [Time frame: Measurement of change: before treatment (baseline), at two months (mid-treatment), at five months (end of treatment), and at 7 months of treatment (follow-up period)
Secondary outcomes:
Other outcomes:
Locations:
city: Alcantarilla
country: Spain
facility: AFADE: Association of relatives of Alzheimer's and other dementias
state: Murcia
city: Murcia
country: Spain
facility: AFAMUR, Association of relatives of Alzheimer&#39;s patients
Study officials:
affiliation: Universidad de Murcia
name: Esther del Carmen Teruel Hernández, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Murcia
name: Antonia Gomez-Conesa., Ph. D.
role: STUDY_DIRECTOR
affiliation: Universidad de Murcia
name: Jose A. Lopez Pina, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of A Coruña
name: Sonia Souto Camba, Ph.D.
role: STUDY_DIRECTOR
References: