Non-invasive Stimulation Through Nesa and Therapeutic Exercise on Sleep Disturbances on Alzheimer's Disease Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2022-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Resistive Exercise on Insomnia in Post Menopausal Women

NCT05556317

Sleep Disturbances and Insomnia

UNKNOWN NA

Resistance Training and Sleep in the Elderly

NCT01404286

SLEEP DISTURBANCES Nec in ICD9CM

COMPLETED NA

Brain Gym Therapy on Quality of Sleep Among Elderly People

NCT06553690

Sleep Disorder Insomnia Cognitive Function Abnormal +2 more

NOT_YET_RECRUITING NA

Effects of Walking Exercise on Sleep Quality in Older Adults

NCT07027176

Sleep Quality Cognitive Function

NOT_YET_RECRUITING NA

Emotional Intelligence and Relaxation Techniques for Mental Health and Sleep in Older Adults

NCT06671574

Older People

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random intervention model

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The evaluators of all the results and the main caregivers of the participating patients will be masked.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-invasive neurostimulation experimental group (NEG)

The non-invasive neuromodulation experimental group, made up of 10 participants, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA)

Group Type EXPERIMENTAL

non-invasive neuromodulation through the Nesa device

Intervention Type DEVICE

patients receive non-invasive neurostimulation through the Nesa device

Experimental group Therapeutic Exercise (TEG)

The experimental group of therapeutic exercise, made up of 10 participants, receives 3 weekly sessions of one hour duration for 16 weeks, and 1 weekly session until week 20, of an adapted program of cardiovascular exercises in a small group format, supervised by a physical therapist.

Group Type EXPERIMENTAL

therapeutic exercise

Intervention Type PROCEDURE

patients receive adapted therapeutic exercise

Control group (CG)

The control group, made up of 10 participants, the caregivers receive recommendations about sleep habits through an information brochure.

Group Type SHAM_COMPARATOR

sleep hygiene measures

Intervention Type BEHAVIORAL

caregivers receive a brochure with sleep hygiene measures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-invasive neuromodulation through the Nesa device

patients receive non-invasive neurostimulation through the Nesa device

Intervention Type DEVICE

therapeutic exercise

patients receive adapted therapeutic exercise

Intervention Type PROCEDURE

sleep hygiene measures

caregivers receive a brochure with sleep hygiene measures

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No