Concussion, MildNCT06328023
Impact of Concussion History on Sleep and Physical Performance in Contact Sports Athletes
An observational study of Concussion, Mild and Sleep, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. Read more about this study
- Who is it for?
- Ages 18 to 36 years
- Conditions the study is for
- Concussion, Mild, Sleep, Physical Performance
- What is being tested?
- SCOAT 6 to find association
- How many people
- 115 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Mar 2024to 2 Jun 2024
- Phase
- Observational
- 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 18 to 36 years
- All sexes
- Adult
Study population: The athletes will be from contact sports s they are more prone to concussion
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Active Male Combat sports player.
- Age between 18-25 years.
- Athletes who had a hit on jaw, neck, head and had symptom of concussion discussed under heading of Introduction.
- Athlete who had history of concussion between 3-30 days.
- Mild concussion according to CANTU NO LOC PTA
Who cannot join
- Participants fall in this category would be excluded of the study.
- Concussion other than sports.
- History of metabolic diseases.
- History of recent fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
HAYATABAD Sports complex
Peshawar, Khyber Pakhtun Khawan, 24730
Nadia Ishtiaq, MSOMPT, 03486977541, Nadia.Ishtiaq@riphah.edu.pk
Muhammad haroon, MSSPT*, 03484644733, muhammad-haroon6528@zu.edu.pk
About this study
Official title: Association of History of Concussion With Sleep and Physical Performance in Contact Sports Athletes
This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports
Read the detailed description
This study delves into the intricate relationship between the history of concussions, sleep quality, and physical performance among athletes participating in contact sports. Concussions, often occurring due to the high-impact nature of these sports, have raised concerns regarding their potential long-term effects on athletes' health and performance. This research aims to elucidate whether a history of concussions influences athletes' sleep patterns and subsequently affects their physical performance.
The study employs a comprehensive approach, utilizing both subjective and objective measures to assess sleep quality, such as self-reported sleep disturbances and objective sleep monitoring techniques. Furthermore, various metrics are employed to evaluate physical performance, including agility, strength, speed, and endurance tests tailored to the specific demands of contact sports.
By analyzing the data collected from athletes with and without a history of concussions, the study aims to identify potential correlations between concussion history, sleep disturbances, and diminished physical performance. Additionally, the research seeks to uncover any potential mediating factors, such as psychological distress or neurocognitive deficits, which may contribute to these associations.
The findings of this study hold significant implications for athlete well-being and sports medicine practices. Understanding the impact of concussions on sleep quality and physical performance can inform tailored interventions and rehabilitation strategies to mitigate the adverse effects of concussions on athletes' health and optimize their performance outcomes in contact sports. Moreover, these insights may contribute to the development of preventive measures and policies aimed at reducing the incidence and severity of concussions in sports settings.
- Conditions
- Concussion, Mild, Sleep, Physical Performance
- Being tested
- SCOAT 6 to find association
- Keywords
- Contact sports
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCOAT 6 to find associationOther
we will use SCOAT 6 to find the association between concussion , sleep and physical performance
What is being measured
The primary outcome is the main question the study is designed to answer.
Cantu Scale
First we have to identify mild concussion which can be done by CANTU SCALE DEVELOPED BY DR ROBER CANTU It has following description In Grade 1 concussions, there may be brief confusion or disorientation immediately following the injury, but there is no loss of consciousness or post-traumatic amnesia. Symptoms resolve within 15 minutes.(MODERATE) Grade 2 concussions involve a loss of consciousness lasting less than one minute and post-traumatic amnesia lasting less than 24 hours. Symptoms, however, persist for more than 15 minutes.(MILD) This is the most severe grade on the Cantu Scale. Grade 3 concussions involve a loss of consciousness lasting more than one minute, post-traumatic amnesia lasting more than 24 hours, and symptoms that persist for more than seven days.(SEVERE)
Measured: 3 -30 DAYS
Secondary outcomes (1)
Sport Concussion Office Assessment Tool 6
The SCOAT6 (Sport Concussion Assessment Tool 6) can be used for diagnosis, evaluation, management, and referral for sports-related concussions. It includes:
History Global symptom scale total symptom number 25 symptom severity 25x6 Verbal Cognitive Test Months in Reverse Order Vital Signs Monitoring Cervical Spine Assessment Neurological Examination Balance Assessment: BESS total 30 10 forrorr each task and score 1 for 1 error Modified Vestibular/Ocular-Motor Screening (mVOMS): 0 -10 4 maybe concussed Anxiety(GAD-7), Depression(PHQ-2), and Sleep Screening ASSQ
\Graded Exercise Protocols
Measured: 3 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start18 Mar 2024
- Primary completion23 Apr 2024 (estimated)
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia ishtiaq, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328023
- Sponsor's protocol ID
- REC/MS-PT/01831
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arliani GG, Astur DC, Yamada RK, Yamada AF, da Rocha Correa Fernandes A, Ejnisman B, de Castro Pochini A, Cohen M. Professional football can be considered a healthy sport? Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3907-3911. doi: 10.1007/s00167-015-3636-2. Epub 2015 May 17.
PubMed 25982623Hall Z, Baxter G, Dong NX, Chou S-F. Prevention Strategies of Traumatic Brain Injury in Football Players. 2018
Sisodia V, Hamid J, Guru K. Efficacy of vestibular rehabilitation in management of balance deficit in Indian collegiate football players, with sport-related concussion-randomized clinical trial. Physiotherapy. 2015;101:e1403-e4.
Park E, Baker AJ. Translational Mild Traumatic Brain Injury Research: Bridging the Gap Between Models and Clinical Uncertainty. Neurotrauma: A Comprehensive Textbook on Traumatic Brain Injury and Spinal Cord Injury. 2018:271.
Gasquoine PG. Historical perspectives on evolving operational definitions of concussive brain injury: From railway spine to sport-related concussion. Clin Neuropsychol. 2020 Feb;34(2):278-295. doi: 10.1080/13854046.2019.1621383. Epub 2019 May 31.
PubMed 31146639Broglio SP, Collins MW, Williams RM, Mucha A, Kontos AP. Current and emerging rehabilitation for concussion: a review of the evidence. Clin Sports Med. 2015 Apr;34(2):213-31. doi: 10.1016/j.csm.2014.12.005. Epub 2015 Jan 24.
PubMed 25818710Clark MD, Asken BM, Marshall SW, Guskiewicz KM. Descriptive Characteristics of Concussions in National Football League Games, 2010-2011 to 2013-2014. Am J Sports Med. 2017 Mar;45(4):929-936. doi: 10.1177/0363546516677793. Epub 2017 Jan 5.
PubMed 28056179O'Connor KL, Rowson S, Duma SM, Broglio SP. Head-Impact-Measurement Devices: A Systematic Review. J Athl Train. 2017 Mar;52(3):206-227. doi: 10.4085/1062-6050.52.2.05.
PubMed 28387553Collins MW, Sandel N, Norwig JA, Ruef S. Sport-related Concussion: Experience from the National Football League. Return to Play in Football: Springer; 2018. p. 699-711.
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
PubMed 16983222Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
PubMed 20588094McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.
PubMed 14625332Balatsouras DG, Koukoutsis G, Aspris A, Fassolis A, Moukos A, Economou NC, Katotomichelakis M. Benign Paroxysmal Positional Vertigo Secondary to Mild Head Trauma. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):54-60. doi: 10.1177/0003489416674961. Epub 2016 Oct 25.
PubMed 27780909Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.
PubMed 27655831Gurr B, Moffat N. Psychological consequences of vertigo and the effectiveness of vestibular rehabilitation for brain injury patients. Brain Inj. 2001 May;15(5):387-400. doi: 10.1080/02699050010005904.
PubMed 11350653
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of History of Concussion With Sleep and Physical Performance in Contact Sports Athletes
- ClinicalTrials.gov ID
- NCT06328023
- Acronym / sponsor ID
- REC/MS-PT/01831
- Conditions
- Concussion, Mild, Sleep, Physical Performance
- Keywords
- Contact sports
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 23 Apr 2024 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 25 Mar 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 study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports
Detailed description
This study delves into the intricate relationship between the history of concussions, sleep quality, and physical performance among athletes participating in contact sports. Concussions, often occurring due to the high-impact nature of these sports, have raised concerns regarding their potential long-term effects on athletes' health and performance. This research aims to elucidate whether a history of concussions influences athletes' sleep patterns and subsequently affects their physical performance.
The study employs a comprehensive approach, utilizing both subjective and objective measures to assess sleep quality, such as self-reported sleep disturbances and objective sleep monitoring techniques. Furthermore, various metrics are employed to evaluate physical performance, including agility, strength, speed, and endurance tests tailored to the specific demands of contact sports.
By analyzing the data collected from athletes with and without a history of concussions, the study aims to identify potential correlations between concussion history, sleep disturbances, and diminished physical performance. Additionally, the research seeks to uncover any potential mediating factors, such as psychological distress or neurocognitive deficits, which may contribute to these associations.
The findings of this study hold significant implications for athlete well-being and sports medicine practices. Understanding the impact of concussions on sleep quality and physical performance can inform tailored interventions and rehabilitation strategies to mitigate the adverse effects of concussions on athletes' health and optimize their performance outcomes in contact sports. Moreover, these insights may contribute to the development of preventive measures and policies aimed at reducing the incidence and severity of concussions in sports settings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Age groups
- Adult
- Study population
- The athletes will be from contact sports s they are more prone to concussion
Key inclusion criteria (6 listed)
- Participants falling in this category would be recruited into the study.
- Active Male Combat sports player.
- Age between 18-25 years.
- Athletes who had a hit on jaw, neck, head and had symptom of concussion discussed under heading of Introduction.
- Athlete who had history of concussion between 3-30 days.
Key exclusion criteria (4 listed)
- Participants fall in this category would be excluded of the study.
- Concussion other than sports.
- History of metabolic diseases.
- History of recent fractures
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 |
|---|---|---|
| SCOAT 6 to find associationwe will use SCOAT 6 to find the association between concussion , sleep and physical performance | Other | – |
Primary outcome
Cantu Scale
Time frame: 3 -30 DAYS
First we have to identify mild concussion which can be done by CANTU SCALE DEVELOPED BY DR ROBER CANTU It has following description In Grade 1 concussions, there may be brief confusion or disorientation immediately following the injury, but there is no loss of consciousness or post-traumatic amnesia. Symptoms resolve within 15 minutes.(MODERATE) Grade 2 concussions involve a loss of consciousness lasting less than one minute and post-traumatic amnesia lasting less than 24 hours. Symptoms, however, persist for more than 15 minutes.(MILD) This is the most severe grade on the Cantu Scale. Grade 3 concussions involve a loss of consciousness lasting more than one minute, post-traumatic amnesia lasting more than 24 hours, and symptoms that persist for more than seven days.(SEVERE)
1 secondary outcome
Sport Concussion Office Assessment Tool 6
Time frame: 3 to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 25982623Arliani GG, Astur DC, Yamada RK, Yamada AF, da Rocha Correa Fernandes A, Ejnisman B, de Castro Pochini A, Cohen M. Professional football can be considered a healthy sport? Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3907-3911. doi: 10.1007/s00167-015-3636-2. Epub 2015 May 17.
- BackgroundHall Z, Baxter G, Dong NX, Chou S-F. Prevention Strategies of Traumatic Brain Injury in Football Players. 2018
- BackgroundSisodia V, Hamid J, Guru K. Efficacy of vestibular rehabilitation in management of balance deficit in Indian collegiate football players, with sport-related concussion-randomized clinical trial. Physiotherapy. 2015;101:e1403-e4.
- BackgroundPark E, Baker AJ. Translational Mild Traumatic Brain Injury Research: Bridging the Gap Between Models and Clinical Uncertainty. Neurotrauma: A Comprehensive Textbook on Traumatic Brain Injury and Spinal Cord Injury. 2018:271.
- Background: PubMed 31146639Gasquoine PG. Historical perspectives on evolving operational definitions of concussive brain injury: From railway spine to sport-related concussion. Clin Neuropsychol. 2020 Feb;34(2):278-295. doi: 10.1080/13854046.2019.1621383. Epub 2019 May 31.
- Background: PubMed 25818710Broglio SP, Collins MW, Williams RM, Mucha A, Kontos AP. Current and emerging rehabilitation for concussion: a review of the evidence. Clin Sports Med. 2015 Apr;34(2):213-31. doi: 10.1016/j.csm.2014.12.005. Epub 2015 Jan 24.
- Background: PubMed 28056179Clark MD, Asken BM, Marshall SW, Guskiewicz KM. Descriptive Characteristics of Concussions in National Football League Games, 2010-2011 to 2013-2014. Am J Sports Med. 2017 Mar;45(4):929-936. doi: 10.1177/0363546516677793. Epub 2017 Jan 5.
- Background: PubMed 28387553O'Connor KL, Rowson S, Duma SM, Broglio SP. Head-Impact-Measurement Devices: A Systematic Review. J Athl Train. 2017 Mar;52(3):206-227. doi: 10.4085/1062-6050.52.2.05.
- BackgroundCollins MW, Sandel N, Norwig JA, Ruef S. Sport-related Concussion: Experience from the National Football League. Return to Play in Football: Springer; 2018. p. 699-711.
- Background: PubMed 16983222Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
- Background: PubMed 20588094Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
- Background: PubMed 14625332McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.
- Individual participant dataSharing planned: No
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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.
Nadia ishtiaq, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild and Sleep, run by Riphah International University at 1 site in Pakistan.
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 6 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Nadia Ishtiaq, MSOMPT (03486977541, Nadia.ishtiaq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cantu Scale (time frame: 3 -30 DAYS). 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 NCT06328023, which also lists 17 linked publications.
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 27 Mar 2024.