Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868798
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2023-05-03
Brief Title:
Can Ammonium Inhalants Maintain Performance in Sleep Deprived Soldiers
Sponsor:
Jan Malecek
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Effects of 36 Hours of Sleep Deprivation on Military-related Tasks Can Ammonium Inhalants Maintain Performance
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to examine the effectiveness of ammonia inhalants in countering the effects of total sleep deprivation on cognitive and physical performance tests relevant to military personnel
Detailed Description:
Data from this study are part of a broader research project aimed at investigating the effects of different light conditions on cognitive and physiological performance during periods of total sleep deprivation We used a crossover randomized controlled trial design with within-subject repeated-measures to assess the effects of 36 hours of total sleep deprivation and acute ammonia inhalation on occupationally relevant military tasks in military personnel
Participants reported to the Sleep and Chronobiology laboratory National Institute of Mental Health on Thursday evening after a standardized dinner at 1800 h They then completed a series of questionnaires addressing psychological and physiological health which were followed by a general familiarization of the layout of the facility ie location of the bathrooms testing stations etc During this familiarization the participants were also familiarized with the specific testing procedures and practiced each of the required tasks
The actual testing protocol began with a night of uninterrupted sleep from 2200 h to 0630 h Participants then underwent 5 identical testing sessions from every 0730-0930 h in the morning and 1900-2100 h in the evening The first test occurred in the morning after the full night of baseline sleep 0 h and again after 12 hours -12 h 24 hours -24 h and 36 hours of total sleep deprivation -36 h followed by additional testing session after 8 hours from 2230-0630 h of recovery sleep 8 h During total sleep deprivation participants were not allowed to sleep and were kept awake in a common room by passive means such as playing board games watching television and reading books while under constant supervision of the research team Furthermore the participants were subjected to a constant ambient room light for the entire duration of total sleep deprivation period
Participants were administered a standardized sleepiness scale and underwent simple reaction time testing handgun shooting accuracy protocol a rifle disassembly and reassembly protocol and countermovement jump testing at each testing session Participants performed each individual test twice at each testing period either with AI AI or without AI CON in randomized order and separated by 2 minutes of rest in order to minimize any potential carryover effects of the AI
For all AI trials a capsule containing 03 mL of AI composed of 15 of ammonia and 35 of alcohol 31 was used according to the manufacturers instructions Dynarex Corporation Orangeburg NY When the ammonia fumes were released researcher immediately held the capsule under the participants nose to inhale until a voluntary withdrawal reflex was observed
During the entire study protocol participants received personalized daily food rations consisting of standard ready to eat meals commonly used in the Czech military One week before the experiment participants body composition was measured using air displacement plethysmography Bod Pod Body Composition System Life Measurement Instruments Concord CA and the total daily energy expenditure was derived from the estimated resting metabolic rate and application of an active physical activity factor of 16 to the individual caloric requirements In addition each participant was allowed ad libitum water consumption Breakfast was consumed at 0930 h lunch at 1230 h and dinner at 1730 h each day Additionally all forms of stimulants were prohibited 72 hours before and during the testing protocol
Participants reported to the Sleep and Chronobiology laboratory National Institute of Mental Health on Thursday evening after a standardized dinner at 1800 h They then completed a series of questionnaires addressing psychological and physiological health which were followed by a general familiarization of the layout of the facility ie location of the bathrooms testing stations etc During this familiarization the participants were also familiarized with the specific testing procedures and practiced each of the required tasks
The actual testing protocol began with a night of uninterrupted sleep from 2200 h to 0630 h Participants then underwent 5 identical testing sessions from every 0730-0930 h in the morning and 1900-2100 h in the evening The first test occurred in the morning after the full night of baseline sleep 0 h and again after 12 hours -12 h 24 hours -24 h and 36 hours of total sleep deprivation -36 h followed by additional testing session after 8 hours from 2230-0630 h of recovery sleep 8 h During total sleep deprivation participants were not allowed to sleep and were kept awake in a common room by passive means such as playing board games watching television and reading books while under constant supervision of the research team Furthermore the participants were subjected to a constant ambient room light for the entire duration of total sleep deprivation period
Participants were administered a standardized sleepiness scale and underwent simple reaction time testing handgun shooting accuracy protocol a rifle disassembly and reassembly protocol and countermovement jump testing at each testing session Participants performed each individual test twice at each testing period either with AI AI or without AI CON in randomized order and separated by 2 minutes of rest in order to minimize any potential carryover effects of the AI
For all AI trials a capsule containing 03 mL of AI composed of 15 of ammonia and 35 of alcohol 31 was used according to the manufacturers instructions Dynarex Corporation Orangeburg NY When the ammonia fumes were released researcher immediately held the capsule under the participants nose to inhale until a voluntary withdrawal reflex was observed
During the entire study protocol participants received personalized daily food rations consisting of standard ready to eat meals commonly used in the Czech military One week before the experiment participants body composition was measured using air displacement plethysmography Bod Pod Body Composition System Life Measurement Instruments Concord CA and the total daily energy expenditure was derived from the estimated resting metabolic rate and application of an active physical activity factor of 16 to the individual caloric requirements In addition each participant was allowed ad libitum water consumption Breakfast was consumed at 0930 h lunch at 1230 h and dinner at 1730 h each day Additionally all forms of stimulants were prohibited 72 hours before and during the testing protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None