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

NCT05715866 | Completed

• 1 other identifier: ET_2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; sleep disorders

Outcome Measures

Primary Outcomes (3)

• Change in sleep quality

  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.

  [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)

• Change in cognitive status

  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)

  [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)

• Change in quality of life

  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.

  [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)

Study Arms (3)

non-invasive neurostimulation experimental group (NEG)

EXPERIMENTAL

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

Device: non-invasive neuromodulation through the Nesa device

Experimental group Therapeutic Exercise (TEG)

EXPERIMENTAL

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.

Procedure: therapeutic exercise

Control group (CG)

SHAM COMPARATOR

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

Behavioral: sleep hygiene measures

Interventions

non-invasive neuromodulation through the Nesa device DEVICE

patients receive non-invasive neurostimulation through the Nesa device

non-invasive neurostimulation experimental group (NEG)

therapeutic exercise PROCEDURE

patients receive adapted therapeutic exercise

Experimental group Therapeutic Exercise (TEG)

sleep hygiene measures BEHAVIORAL

caregivers receive a brochure with sleep hygiene measures

Control group (CG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (2)

AFADE: Association of relatives of Alzheimer's and other dementias

Alcantarilla, Murcia, 30820, Spain

Location

AFAMUR, Association of relatives of Alzheimer's patients

Murcia, 30100, Spain

Location

Related Publications (1)

• Teruel-Hernandez E, Lopez-Pina JA, Souto-Camba S, Baez-Suarez A, Medina-Ramirez R, Gomez-Conesa A. Improving Sleep Quality, Daytime Sleepiness, and Cognitive Function in Patients with Dementia by Therapeutic Exercise and NESA Neuromodulation: A Multicenter Clinical Trial. Int J Environ Res Public Health. 2023 Nov 6;20(21):7027. doi: 10.3390/ijerph20217027.

  PMID: 37947583 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Sleep Wake Disorders

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Esther del Carmen Teruel Hernández, MsC

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

• Antonia Gomez-Conesa., Ph. D.

  Universidad de Murcia

  STUDY DIRECTOR

• Jose A. Lopez Pina, Ph.D.

  Universidad de Murcia

  STUDY DIRECTOR

• Sonia Souto Camba, Ph.D.

  Universidade da Coruña

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluators of all the results and the main caregivers of the participating patients will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Random intervention model

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: December 7, 2021
• Primary Completion: June 17, 2022
• Study Completion: August 22, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)