NESA Microcurrents on Quality of Life in Geriatric Patients

NCT05800431 | Completed

• 1 other identifier: QueeNesa
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, the population of older adults (MA) in the world has been increasing, due to the increase in life expectancy and the decrease in the fertility rate. The United Nations (UN) places Spain as the most aged country in the world in the year 2050, with 40% of its population over 60 years of age. There is evidence that quality of life in the elderly is associated with variables linked to physical and psychological health. Thus, for example, previous research indicates that perceived health and cognitive functioning influence the perception of quality of life. The NESA XSIGNAL® device is a low-frequency, non-invasive neuromodulation device that uses microcurrents to restore electrical balance in the body. This technology is approved as medical equipment and is CE marked. This non-invasive neuromodulation equipment is starting to have promising results in patients with sleep disorders. So it can be a useful tool to reduce the impact on the geriatric patient's quality of life.

Conditions

Aging

Keywords

physical therapy modality; sleep disorders; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Change in sleep quality

  The investigators want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) will be combined to report changes in the patient's sleep quality. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep

  Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)

• Change in quality of life

  The investigators want to see if the quality of life of patients improves when their relatives receive treatment. The Spanish version of the World Health Organization Quality of Life of Older Adults (WHOQOL-OLD) scale will be used. The WHOQOL-OLD is made up of 24 Likert-type scale items divided into six areas Likert-type scale, divided into six areas: sensory skills, autonomy, past activities abilities, autonomy, past, present and future activities, social participation, death and intimacy. Each of these areas contains four items, with a final score ranging from 4 to 20, provided that all items in the same area have been completed. The higher the score, the better the quality of life in each area.

  Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)

• Changes in mood

  The investigators will use the Geriatric Depression Scale (GDS). This is a questionnaire for screening for depression in people over 65 years of age. The main caregiver must answer 15 questions, one point is assigned for each answer that matches the one reflected on the side (affirming depression). The cut-off points are: * normal: 0 to 5 points * moderate depression: 6 to 10 points; * severe depression: more than 10 points.

  Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

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

Device: Non-invasive neuromodulation through the Nesa device

Control group (CG)

NO INTERVENTION

Conventional care will be performed without interrupting their normal activity.

Interventions

Non-invasive neuromodulation through the Nesa device DEVICE

patients receive non-invasive neurostimulation through the Nesa device

Non-invasive Neuromodulation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients residing in the social-health care center under study.
• Stable medical and pharmacological condition.
• No cognitive impairment or mild cognitive impairment.

You may not qualify if:

• Patients with some of the contraindications for treatment with NESA device: pacemakers, internal bleeding, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity,
• Not having signed the informed consent form.
• Patients with severe cognitive impairment, patients with severe cognitive impairment.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

Aníbal Báez Suárez

Las Palmas de Gran Canaria, Spain, 35018, Spain

Location

Related Publications (4)

• Ogawa T, Koike M. Independent factors that attenuate the effectiveness of fracture rehabilitation in improving activities of daily living in female patients aged 80 years and above. Aging Clin Exp Res. 2022 Apr;34(4):793-800. doi: 10.1007/s40520-021-01992-y. Epub 2021 Oct 8.

  PMID: 34623628 BACKGROUND

• Gottschalk S, Konig HH, Schwenk M, Nerz C, Becker C, Klenk J, Jansen CP, Dams J. Cost-Effectiveness of a Group vs Individually Delivered Exercise Program in Community-Dwelling Persons Aged >/=70 Years. J Am Med Dir Assoc. 2022 May;23(5):736-742.e6. doi: 10.1016/j.jamda.2021.08.041. Epub 2021 Oct 7.

  PMID: 34626579 BACKGROUND

• Tang T, Jiang J, Tang X. Psychological risk and protective factors associated with depression among older adults in mainland China: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2022 Jan;37(1). doi: 10.1002/gps.5637. Epub 2021 Oct 14.

  PMID: 34633701 BACKGROUND

• Coin A, Devita M, Trevisan C, Biasin F, Terziotti C, Signore SD, Fumagalli S, Gareri P, Malara A, Mossello E, Volpato S, Monzani F, Bellelli G, Zia G, Ranhoff AH, Antonelli Incalzi R. Psychological Well-Being of Older Adults With Cognitive Deterioration During Quarantine: Preliminary Results From the GeroCovid Initiative. Front Med (Lausanne). 2021 Sep 22;8:715294. doi: 10.3389/fmed.2021.715294. eCollection 2021.

  PMID: 34631737 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Aníbal Báez Suárez, PhD

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The evaluators of all the results and the main caregivers of the participating patients will be masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 5, 2023
• Study Start: August 1, 2023
• Primary Completion: February 27, 2024
• Study Completion: April 3, 2024
• Last Updated: March 27, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)