Sleep DisorderBG/ENCT06553690
Brain Gym Therapy on Quality of Sleep Among Elderly People
A study testing Brain Gym Therapy in people with Sleep Disorder and Insomnia, run by Cairo University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Insomnia, Cognitive Function Abnormal
- What is being tested?
- Brain Gym Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 12 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Disorder, Insomnia, Cognitive Function Abnormal, Old Age; Debility, Brain Gym Therapy
- Being tested
- Brain Gym Therapy
- Keywords
- Brain Gym Therapy, Sleep Quality, Cognitive Exercise, Non-Pharmacological Intervention, Insomnia in Elderly
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Cognition Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Gym TherapyOther
Also called non
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Brain Gym Therapy. | Experimental | 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. Receives: Other: Brain Gym Therapy |
| Participants receiving standard care without Brain Gym Therapy | No intervention | standered care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Sleep Quality
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.
Measured: Baseline, Week 4 (post-intervention), and Week 8 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion11 Oct 2024 (estimated)
- Study completion12 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553690
- Sponsor's protocol ID
- braingym
- Other IDs
- HAP-13-S-001
- Acronym
- BG/E
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alanazi MA, Shaban M, Zaky ME. Impact of brain gym therapy on quality of sleep among older adults attending health care facilities. Geriatr Nurs. 2025 Jul-Aug;64:103431. doi: 10.1016/j.gerinurse.2025.103431. Epub 2025 Jun 27.
PubMed 40580820
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brain Gym Therapy on Quality of Sleep Among Elderly People Attending Health Care Facilities
- ClinicalTrials.gov ID
- NCT06553690
- Acronym / sponsor ID
- BG/E / braingym
- Conditions
- Sleep Disorder, Insomnia, Cognitive Function Abnormal, Old Age; Debility, Brain Gym Therapy
- Keywords
- Brain Gym Therapy, Sleep Quality, Cognitive Exercise, Non-Pharmacological Intervention, Insomnia in Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 11 Oct 2024 (estimated)
- Study completion
- 12 Oct 2024 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Brain Gym Therapy. | Experimental | Other: Brain Gym TherapyParticipants 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. |
| Participants receiving standard care without Brain Gym Therapy | No intervention | –standered care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Gym TherapyAlso: nonBrain 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 | Participants receiving Brain Gym Therapy. |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 40580820Alanazi MA, Shaban M, Zaky ME. Impact of brain gym therapy on quality of sleep among older adults attending health care facilities. Geriatr Nurs. 2025 Jul-Aug;64:103431. doi: 10.1016/j.gerinurse.2025.103431. Epub 2025 Jun 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Gym Therapy in people with Sleep Disorder and Insomnia, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Sleep Quality (time frame: Baseline, Week 4 (post-intervention), and Week 8 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.