Brain Gym Therapy on Quality of Sleep Among Elderly People (BG/E)

August 11, 2024 updated by: Mostafa Shaban, Cairo University

Impact of Brain Gym Therapy on Quality of Sleep Among Elderly People Attending Health Care Facilities

This clinical trial aims to evaluate the impact of Brain Gym Therapy on the quality of sleep among elderly individuals attending healthcare facilities. The study will explore whether this non-pharmacological intervention can improve sleep quality, which is often compromised in the elderly population due to various health conditions and age-related changes. Participants will undergo Brain Gym Therapy sessions over a specified period, and their sleep quality will be assessed using validated sleep measurement tools. The findings may provide insights into alternative methods for enhancing sleep in older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study investigates the effects of Brain Gym Therapy on the quality of sleep among elderly individuals who are receiving care at healthcare facilities. Brain Gym Therapy, a series of physical activities designed to enhance cognitive functions, has been hypothesized to positively influence sleep patterns by reducing stress, improving relaxation, and enhancing overall mental well-being.

The study will employ a randomized controlled trial design, with participants being randomly assigned to either an intervention group receiving Brain Gym Therapy or a control group receiving standard care without the therapy. The intervention will consist of structured Brain Gym exercises conducted by trained practitioners, focusing on movements that are believed to stimulate brain function and promote relaxation.

Participants will be elderly individuals aged 65 and above, attending healthcare facilities, and experiencing issues with sleep quality. Exclusion criteria will include individuals with severe cognitive impairments, those currently undergoing other sleep interventions, or those with contraindications to physical activity.

The primary outcome measure will be the quality of sleep, assessed using validated sleep questionnaires such as the Pittsburgh Sleep Quality Index (PSQI), alongside secondary outcomes including sleep latency, duration, and efficiency. Data will be collected at baseline, mid-intervention, and post-intervention, with follow-up assessments to determine the sustainability of any observed effects.

The study aims to contribute to the growing body of evidence supporting non-pharmacological interventions for sleep improvement in the elderly, potentially offering a viable alternative to medication for managing sleep disturbances in this population. Ethical approval has been obtained, and all participants will provide informed consent before participation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Elderly individuals aged 60 years and above. Attending healthcare facilities and able to participate in the study. Experiencing issues with sleep quality, as determined by a score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI).

Willing and able to provide informed consent. Physically capable of performing gentle physical exercises as part of Brain Gym Therapy

Exclusion Criteria:

Severe cognitive impairment or dementia that would impede understanding or participation in the intervention.

Current participation in another sleep intervention study. Presence of severe medical conditions that contraindicate physical activity (e.g., severe cardiovascular disease, musculoskeletal disorders).

Use of sleep medications that could confound the study results. Recent history (within the past 6 months) of major psychiatric disorders, including severe depression or anxiety.

Any condition that, in the opinion of the investigators, would make participation unsafe or not in the best interest of the participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants receiving Brain Gym Therapy.
Participants in this arm will undergo Brain Gym Therapy, which consists of a series of structured physical exercises designed to enhance cognitive function and promote relaxation.
Other: Brain Gym Therapy
Brain Gym Therapy is a structured program of physical movements designed to enhance cognitive function, reduce stress, and promote relaxation. The therapy is based on the principle that specific physical activities can stimulate brain function and improve overall mental and physical well-being.
Other Names:
  • non
No Intervention: Participants receiving standard care without Brain Gym Therapy
standered care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in Sleep Quality
Time Frame: Baseline, Week 4 (post-intervention), and Week 8 (follow-up)
The primary outcome measure will assess the improvement in sleep quality among elderly participants who undergo Brain Gym Therapy compared to those receiving standard care. Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a validated and widely used instrument that measures various aspects of sleep including duration, latency, efficiency, disturbances, and subjective sleep quality. The PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline, Week 4 (post-intervention), and Week 8 (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • braingym
  • HAP-13-S-001 (Other Identifier: Jouf university)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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