Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202409572874948 Date of Registration: 19/09/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of acute acetaminophen ingestion and effect of two nap durations on short-duration peak performance, subjective cognitive performance, and state of mind in young athletes who underwent a night of nocturnal sleep restriction.
Official scientific title Effect of acute acetaminophen ingestion and the effect of two nap durations on short-term maximal performance, subjective cognitive performance, and mood state in young athletes with partial nocturnal sleep deprivation.
Brief summary describing the background and objectives of the trial Abstract: This study examines the effects of 40- and 90-minute naps, as well as the acute ingestion of 1.5 g of acetaminophen (paracetamol), on cognitive and physical performance after one night of normal sleep and one night of sleep restriction. Context: Sleep deprivation can impair cognitive and physical performance. Naps and acetaminophen are possible interventions to mitigate these effects, but their precise impacts under normal and restricted sleep conditions are not well documented. This study aims to fill this gap by assessing their effectiveness in different sleep contexts.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied healthy participants
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 10/06/2022
Actual trial start date 17/06/2022
Anticipated date of last follow up 10/08/2022
Actual Last follow-up date 17/08/2022
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
Recruitment status Completed
Publication URL https://link.springer.com/article/10.1007/s00421-024-05534-y
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group For Experimental Group only 1.5g of paracetamol an acute dose, i.e. a single dose participants were assigned to a placebo (PLA; Maltodextrin) or participants a 1.5 g of paracetamol -Group 1 (7 participants): -4 participants receive placebo -3 participants receive paracetamol -Group 2 (8 participants): -4 participants receive placebo -4 participants receive paracetamol 15
Control Group improving physical and cognitive performance 1.5 g of paracetamol acute ingestion, i.e. a single dose -Group 1 (7 participants): -4 participants receive placebo -3 participants receive paracetamol -Group 2 (8 participants): -4 participants receive placebo -4 participants receive paracetamol 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were in good health, did not suffer from kidney or liver disease, consumed alcohol smoked cigarettes used anti-inflammatory and analgesic substances (prescription or over-the-counter), Adult: 18 Year(s)-44 Year(s) 18 Day(s) 25 Day(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/06/2022 the personal protection committee
Ethics Committee Address
Street address City Postal code Country
the route ain 0.5 km sfax sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of this thesis was to study the effects of napping and acute acetaminophen ingestion on cognitive and physical performance after a night of normal sleep (NSN) and a night of sleep restriction (NRS). The different studies aimed to examine: (i) pain perception (PP), perceived exertion (RPE), delayed onset muscle soreness (DOMS), and perceived recovery (PRS) in response to the 5-m maximal shuttle run test (5SRT), (ii) changes in cognitive, physical, and perceptual responses after acute ingestion of 1.5 g acetaminophen (APAP) and after a 40-minute nap (ST40), (iii) comparison of physical, cognitive, and perceptual responses between N40 and a 90-minute nap (ST90) after NSN and NRS (iv) after NSN physical, cognitive, and perceptual responses during the 5SRT after acute APAP ingestion (v) after acute APAP ingestion, physical, cognitive, and perceptual responses after NSN and NRS. Acute ingestion of paracetamol 60 minutes before the physical test and 45 minutes before the cognitive test.
Secondary Outcome The aim of this thesis was to study the effects of napping and acute acetaminophen ingestion on cognitive and physical performance after a night of normal sleep (NSN) and a night of sleep restriction (NRS). The different studies aimed to examine: (i) pain perception (PP), perceived exertion (RPE), delayed onset muscle soreness (DOMS), and perceived recovery (PRS) in response to the 5-m maximal shuttle run test (5SRT), (ii) changes in cognitive, physical, and perceptual responses after acute ingestion of 1.5 g acetaminophen (APAP) and after a 40-minute nap (ST40), (iii) comparison of physical, cognitive, and perceptual responses between N40 and a 90-minute nap (ST90) after NSN and NRS (iv) after NSN physical, cognitive, and perceptual responses during the 5SRT after acute APAP ingestion (v) after acute APAP ingestion, physical, cognitive, and perceptual responses after NSN and NRS. Acute ingestion of paracetamol 60 minutes before the physical test and 45 minutes before the cognitive test.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
local sports clubs routa matar sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
isseps laboratory route aeport sfax 3080 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor isseps the route matar sfax Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hamdi chtourou h_chtourou@yahoo.fr +2169949482 the route matar
City Postal code Country Position/Affiliation
sfax 3080 Tunisia Doctor position in isseps
Role Name Email Phone Street address
Public Enquiries omar boukhris omarboukhris24@yahoo.com +21620857259 the route ain
City Postal code Country Position/Affiliation
sfax 3029 Tunisia doctor positon in isseps
Role Name Email Phone Street address
Scientific Enquiries atef salem atef.salem95@yahoo.com +21623874933 the route gafssa
City Postal code Country Position/Affiliation
gafssa 4010 Tunisia PhD student position
Role Name Email Phone Street address
Principal Investigator sahar bensalem sahar.bnsalem@gmail.com +21628507442 the route gabess
City Postal code Country Position/Affiliation
sfax 3083 Tunisia PhD student position
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Here are the details concerning the sharing of IPD for our study: Sharing of IPD: 1. Description of Data: The individual patient data (IPD) originates from participants who practice combat sports (English boxing) at local clubs, training regularly 5 days a week with an average of 2 hours per session. Each participant had at least 4 years of sporting experience and participated in at least 4 regional/national competitions per year. Before starting the study, volunteers provided written informed consent and completed a physical activity preparation questionnaire and a paracetamol risk assessment questionnaire (Mauger 2009). The study was conducted in accordance with the Declaration of Helsinki and the protocol was fully validated by the Southern Ethics Committee for the Protection of Persons (CPP SUD N° 0418/2022). Participants were in good health, had no kidney or liver disease, did not use anti-inflammatory or analgesic substances (prescription or over-the-counter), did not consume alcohol, and did not smoke. They were also required not to be taking combined oral contraceptive pills, as these can help stabilize hormonal fluctuations and reduce the perception of experimental pain in women. 2. Procedure for Sharing IPD: The IPD will be accessible through [name of the platform or data repository, "Figshare". Researchers interested in accessing the data will need to submit a formal request using the online form available 3. Security and Confidentiality Measures: De-identification of Data: Data will be anonymized by removing all personally identifiable information and will be coded with anonymized identifiers. Access to IPD will be granted subject to the signing of confidentiality agreements and an evaluation of the intended use of CPP Statistical Analysis Plan,Study Protocol 3 months siesta; paracetamol sport; recovery; fatigue; muscle soreness; mood; attention
URL Results Available Results Summary Result Posting Date First Journal Publication Date
The PDF contains the results of the paracetamol effect and the nap effect. At the moment, I can't divide these results into two separate PDFs. Yes 29/08/2024 11/06/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information