Effect of Non-invasive Stimulation Through Nesa and Therapeutic Exercise on Sleep Disturbances on Alzheimer's Disease Patients. Randomized Multicenter Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Murcia
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change in cognitive status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The evaluators of all the results and the main caregivers of the participating patients will be masked.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: non-invasive neuromodulation through the Nesa device (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.
Intervention: therapeutic exercise (Procedure)
Control group (CG)
The control group, made up of 10 participants, the caregivers receive recommendations about sleep habits through an information brochure.
Intervention: sleep hygiene measures (Behavioral)
Outcomes
Primary Outcomes
Change in cognitive status
Time Frame: [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)
we want to see the cognitive improvement through the Mini-Cognitive Test (Mini-Cognitive Test. Lobo et al. Spanish version of the Mini Examination of the Mental State)
Change in quality of life
Time Frame: [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)
We want to see if the quality of life of caregivers of patients with dementia improves when their relatives receive treatment. The visual analogue scale (EVA) and the caregiver burden scale (Zarit) will be combined to report changes in the caregiver's quality of life.
Change in sleep quality
Time Frame: [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)
We want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) will be combined to report changes in the patient's sleep quality.
Secondary Outcomes
No secondary outcomes reported
Investigators
Esther del Carmen Teruel Hernández
Principal Investigator
Universidad de Murcia