Effects of a Common Cold Treatment on Cognitive Function

Study Overview
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Brief Summary
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A reduction in alertness and lower levels of performance are commonly associated with the common cold. Paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of people suffering from colds. This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering from the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Official Title
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Effects of a Common Cold Treatment on Cognitive Function

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Paracetamol and Caffeine
* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present with symptoms of the common cold of no more than 96 hours duration Score of 2 or more on a self-rating for malaise and at least 4 other cold symptoms Exclusion Criteria: Pregnancy or lactation Hypersensitivity to drugs Have taken caffeine in the last 12 hours or treated their cold

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol and Caffeine<br>Paracetamol and caffeine | Drug: Paracetamol and Caffeine<br>* Paracetamol 1000 mg and caffeine 130 mg<br>|
| Active Comparator: Paracetamol<br>Paracetamol | Drug: Paracetamol<br>* Paracetamol 1000 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. | Baseline to 30 minutes post treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. | Baseline to 60 minutes post treatment administration | 
| Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 
| Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions. | Baseline, 30 minutes and up to 60 minutes post treatment administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetomol, Caffeine, Common cold