| CTRI Number |
CTRI/2019/05/019154 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
14/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Non-invasive techniques to improve sleep disturbance induced cognitive impairments |
|
Scientific Title of Study
|
Sleep Disturbance-Induced Cognitive Impairment in Collegiates: Effects of Brain Wave Entrainment and Aerobic Exercise |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Ejaz Hussain |
| Designation |
Director |
| Affiliation |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia
Jamia Nagar
Jamia Nagar
South
DELHI
110025
India |
| Phone |
9899339816 |
| Fax |
|
| Email |
ehusain@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anam Aseem |
| Designation |
Ph.D. Scholar |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
Jamia Nagar
Jamia Millia Islamia, Maulana Mohammed Ali Jauhar Marg, Jamia Nagar
South
DELHI
110025
India |
| Phone |
8826837035 |
| Fax |
|
| Email |
anam.aseem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anam Aseem |
| Designation |
Ph.D. Scholar |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
Jamia Nagar
Jamia Millia Islamia, Maulana Mohammed Ali Jauhar Marg,Jamia Nagar
South
DELHI
110025
India |
| Phone |
8826837035 |
| Fax |
|
| Email |
anam.aseem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Technology Bhavan New Mehrauli Road, New Delhi, Delhi 110016 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Govt of India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Centre for Physiotherapy and Rehabilitation Sciences |
Jamia Millia Islamia |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Mohammed Ejaz Hussain |
Jamia Millia Islamia |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar
South West
DELHI |
9899339816
ehusain@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep disturbance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercise |
Participants randomly assigned to the aerobic training group will undergo a supervised eight-week intervention where they shall attend three sessions per week for 8 weeks, approximately 45 min per session on treadmill. Training intensity for each participant will be determined using the heart rate maximum (HRmax) obtained during the baseline assessment. Initial training intensity will be set at 65% HRmax (±5 beats per minute), increased by 5% per week to 85% HRmax (±5 beats per minute), and then the intensity will be maintained at 85% HRmax from week 4 to 8 of the intervention. Heart rate will be monitored throughout the training sessions. Each training session will involve a 5 min warm-up stretching before the aerobic exercise and 5 min cool-down period after the exercise. All the participants will also be given sleep hygiene recommendations and they will be asked to follow the same for the course of study. |
| Comparator Agent |
Control group |
Subjects in this group will receive sleep hygiene recommendations and will be asked to follow the same for the complete study duration. |
| Intervention |
Cranial Electrostimulation |
The participants in this group will receive brain wave entrainment treatment via a small, safe, user friendly, hand held device for three times a week for 8 weeks using a micro current cranial electrotherapy stimulator during a nap opportunity of 60 minutes in the afternoon. Based on the CES Ultra manual and the previous researches, current and frequency will be set at 100 μA and 0.5 Hz, respectively. Clip electrodes will be attached to both earlobes to deliver treatment. This group will also be given sleep hygiene recommendations and will be asked to follow the same for the complete study duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Subjects volunteering to participate in the study
A score >5 on Kuppuswamy socio-economic status scale
Physician approval for participation in study program
Subjects having basic understanding of English language
|
|
| ExclusionCriteria |
| Details |
History of any neurological, psychological and psychiatric disorders
History or evidence of cardiovascular disease (history of angina, shortness of breath, uncontrolled hypertension)
Alcoholism and other drug abuse/ smoking
Use of centrally active medications
Use of sleep medications
Receiving any physical therapy intervention or engaged in any regular physical activity program for last 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality and quantity of sleep, Cognitive functions |
Baseline, 4th week, 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective stress, Anxiety, Quality of life, Well being, Biomarkers of sleep and cognition |
Baseline, 4th week, 8th week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/05/2019 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Problems related to sleep are very common in modern society. Consequences of sleep problems can be many out of which decrements in
cognitive performance is amongst the top ranked ill effect. Physiologically, lack of slow wave activity (SWA) occurring during
slow-wave sleep (SWS) is by far the most argued reason for cognitive
decline associated with sleep problems. Moreover, SWA and its coupling with other
sleep features, reorganizes cortical circuitry, supporting cognition. SWA enhancement techniques range from behavioural interventions (such as
various forms of exercises), which have high feasibility but low specificity,
to laboratory based techniques (such as brain wave stimulation), which have
high specificity but are less feasible for widespread use. Here, we propose to examine the effects of two SWA enhancement techniques on sleep and cognitive functions. Therefore, the present study is a randomised, single blinded, multiple arm comparative trial to ascertain the effects of non invasive, non pharmacological SWA enhancement techniques, i.e., Aerobic exercise and Brain wave entrainment on sleep and cognition in collegiate students. Apart from sleep and cognition, this study also intends to investigate the effect of SWA enhancement techniques on stress, anxiety, quality of life, well-being and biomarkers of sleep and cognitive function in sleep disturbed collegiate students. This study is to be conducted in Jamia Millia Islamia. The participants will be recruited from the University campus. If came out with positive results, this study protocol has the potential to be used for improving sleep as well as cognitive functions in
university students. |