Clinical Trial: Effects of a Common Cold Treatment on Cognitive Function

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of a Common Cold Treatment on Cognitive Function

Brief Summary: 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test [ Time Frame: Baseline to 30 minutes post treatment administration ]

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.


Original Primary Outcome: Change from baseline in valid responses to Rapid Visual Information Processing (RVIP) [ Time Frame: 30 minutes post dose ]

Current Secondary Outcome:

  • Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test [ Time Frame: Baseline to 60 minutes post treatment administration ]
    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.
  • Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    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.
  • Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    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.
  • Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    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.
  • Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    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.
  • Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    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.
  • Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    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.
  • Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to res

    Original Secondary Outcome:

    • Change from baseline in valid responses to RVIP [ Time Frame: up to 60 minutes post dose ]
    • Change from baseline Mood Alertness and Physical Sensation Scales (MAPSS) [ Time Frame: up to 60 minutes post dose ]
    • Change from baseline in valid responses to sustained and divided attention task score [ Time Frame: up to 60 minutes post dose ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: November 3, 2011
    Date Started: February 2011
    Date Completion:
    Last Updated: September 25, 2013
    Last Verified: September 2013