| CTRI Number |
CTRI/2025/02/081479 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of forehead cooling on working memory and reaction time in young adults
|
|
Scientific Title of Study
|
Immediate effect of frontal head cooling on working memory performance and auditory reaction time among young adults: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varvanacia Suchiang |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240 |
| Address |
Department of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8794808347 |
| Fax |
|
| Email |
varvanacia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varvanacia Suchiang |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240 |
| Address |
Department of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8794808347 |
| Fax |
|
| Email |
varvanacia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin V P |
| Designation |
Assistant professor |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences , Ujire , Dakshina Kannada , Karnataka-574240 |
| Address |
Department of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences , Ujire , Dakshina Kannada , Karnataka-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9538372524 |
| Fax |
|
| Email |
ashwinvp09@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240 |
|
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Primary Sponsor
|
| Name |
Dr Varvanacia Suchiang |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka-574240 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varvanacia Suchiang |
SDM Yoga and Nature Cure Hospital |
Department of Natural Therapeutics, Shantivana, Dharmasthala, Belthangady, Dakshina Kannada, Karnataka, India 574216
Dakshina Kannada
KARNATAKA |
8794808347
varvanacia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dry head pack |
The subject asked to wear minimal clothing and lie down in a supine position on the massage table and then dry head pack is placed over the subject’s forehead over the area of frontal cortex for 30 mins.
Duration: 30 minutes |
| Intervention |
Frontal head cooling |
Wetted-ice packs were made by placing 200 mL of cubed ice and 300 mL of room-temperature water into the bag. Wetted ice pack containing temperature of 14°C to 16°C. The subject is asked to wear minimal clothing and lie down in a supine position on the massage table and head cooling is placed over the subject’s forehead over the area of frontal cortex for 30mins.The baseline skin temperature will be measured for every 10 min. A digital thermometer is used to keep an eye on the water and pack temperatures.
Duration: 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy young adults
2. Subjects who are willing to participate in the study and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Weak and debilitating individuals
2. Systemic illness
3. Subjects with open wounds
4. Sinusitis
5. Intolerances to cold.
6. Subjects on regular influence of caffeine |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Auditory reaction time
Heart rate variability |
Baseline and immediately after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Digit symbol substitution test
Digit span test
Six - letter cancellation test
|
Baseline and immediately after the intervention |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Forehead cooling have been shown to be involved in the thermoregulation (cooling) of the brain. Head-cooling has been proposed to enhance cognitive function both during and after exercise. Selective head cooling on the surface can be used to cool the grey matter of the brain, as shown by biomedical engineering models. In individuals with insomnia, frontal cerebral thermal treatment decreased frontal cerebral metabolism during sleep. Cooling the forehead simulates a combination of the two mechanisms thought to cool the brain, one being cooling of venous blood by the skin which in turn cools the arterial (carotid) blood supply to the brain. The other major brain cooling mechanism is the dissipation of heat through facial emissary veins or heat loss through the skull. Working memory is the minuscule quantity of information that can be kept in the mind and used for completing cognitive activities, as opposed to long-term memory, which is the vast amount of knowledge maintained during a person’s life. It has been regularly connected to or associated with learning, executive function, intelligence, information processing, understanding, and learning in people of all ages and simplifies thinking, planning, comprehending, and solving problems. The impairment of working memory is thought to be a key cognitive characteristic that distinguishes Attention-Deficits/hyperactivity disorder from Non-attention deficit/ hyper activity disorder. Impaired working memory is a prevalent trait in people with schizophrenia and those at high risk of developing psychosis; it is also a prospective target for early intervention techniques. Benefits of working memory include enhanced attention and processing speed, which can help the brain networks that mediate memory functions more effectively and result in quick reaction times. This study intends to assess the immediate effect of frontal head cooling on working memory performance and auditory reaction time among young adults and to evaluate the changes in cognitive levels following the application of frontal Head cooling.
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