Clinical trial NCT05800431: NESA Microcurrents on Quality of Life in Geriatric Patients
Official title: Efficiency of NESA Microcurrents on Quality of Life in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: physical therapy modality
sleep disorders
Quality of Life
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: The main objective will be to evaluate the efficacy of the application of non-invasive neuromodulation in the treatment of geriatric patients for the improvement of health-related quality of life. For this purpose, the investigators propose to carry out an interventional study with a sample of approximately 40 participants. Data will be recorded for 1 month and a half for each participant.

It is estimated 7 months from the design, management and development of the project, and it does not have sources of financing.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in sleep quality
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)
measure: Change in quality of life
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)
measure: Changes in mood
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Aníbal Báez Suárez
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.