Sleep DeprivationPhase 1NCT05868798
Can Ammonium Inhalants Maintain Performance in Sleep Deprived Soldiers?
A Phase 1 study testing Ammonia Inhalant in people with Sleep Deprivation and Military Activity, run by Jan Malecek at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Military Activity, Sleep
- What is being tested?
- Ammonia Inhalant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2020to 30 Nov 2021
- Phase
- Phase 1
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- passed an annual physical fitness test
- passed medical checkup within the last year
- have at least two years of active-duty service experience
- report a high level of comfort handling firearms
- non-smokers
- currently not working shift-work
- not taking medications known to interfere with sleep, cognitive or physical performance.
Who cannot join
- smoker
- did not pass an annual physical fitness test
- did not pass medical checkup within the last year
- work in Shift-work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 36 Hours of Sleep Deprivation on Military-related Tasks: Can Ammonium Inhalants Maintain Performance?
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.
Read the 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 (i.e., 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 0.3 mL of AI (composed of 15% of ammonia and 35% of alcohol) (31) was used according to the manufacturer's instructions (Dynarex Corporation, Orangeburg, NY). When the ammonia fumes were released, researcher immediately held the capsule under the participant's 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 1.6 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.
- Conditions
- Sleep Deprivation, Military Activity, Sleep, Cognitive Change, Military Combat Stress Reaction
- Being tested
- Ammonia Inhalant
- Keywords
- cognition, military, sleep deprivation, performance, ammonia
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ammonia InhalantDrug
Also called smelling salt
For all AI trials, a capsule containing 0.3 mL of AI (composed of 15% of ammonia and 35% of alcohol) was used according to the manufacturer's instructions (Dynarex Corporation, Orangeburg, NY). When the ammonia fumes were released, researcher immediately held the capsule under the participant's nose to inhale until a voluntary withdrawal reflex was observed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants performed each individual test without ammonia inhalants. |
| Ammonia inhalants | Experimental | Participants performed each individual test with ammonia inhalants. Receives: Drug: Ammonia Inhalant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth sleepiness scale from baseline
We used Epworth Sleepiness Scale (ESS) translated into Czech. It is a self-administered eight-item questionnaire and takes two to three minutes to complete. The questionnaire presents daily lifestyle activities (i.e. reading, watching TV etc.) and participants rate their current self-perceived likelihood of dozing off in each situation, from: "would never doze" (0) to "high chance of dozing". The ESS provides a cumulative score between 0 and 24, with higher numbers indicating greater sleepiness.
Measured: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Change in simple reaction time from baseline
A simple reaction time test was used to assess the speed of responses to visual stimuli. The evaluation of reaction time was performed using the PEBL Version 2.0 software. The test consists of instantaneous responses to a visual stimulus by pressing a spacebar key on a laptop's keyboard as quickly as possible when a visual stimulus appears. In the test, 50 trials of stimuli were presented with an interstimulus interval that randomly varied between 250 ms and 2500 ms. Each participant completed four tests (each time two, either with AI or CON, in randomized order) with 2 minutes of inter-test rest. The simple reaction time data obtained were inspected according to pre-determined criteria, which excluded trial executions that were deemed incorrect due to a reaction time shorter than 150 ms or longer than 3000 ms. The mean reaction time (measured in milliseconds) and the number of incorrect trial executions were used as the variables in the subsequent statistical analysis.
Measured: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Change in handgun shooting accuracy from baseline
A laser-based simulator system with an infrared laser handgun was used to assess handgun shooting accuracy. All trials were performed in the standardized isosceles high-ready stance position. For this study, a real-weight mock-up of the Czech military standard issue Glock 17/22 handgun was used (all participants were familiar with the handgun from their active service). Participants wore over-ear headphones during all testing procedures to hear the software command to start shooting and the simulated shooting blasts when pulling the trigger. A 20 cm circular target was placed on a blank wall 4 meters in front of the participants to simulate a standard-issue 50 cm target 10 meters away for the laser-based handgun shooting protocols. For the testing, participants fired 10 shots, aiming to hit the middle of the circular target (a bullseye hit was worth 10 points, and 1 point was deducted for every 1 cm region away from the bullseye, resulting in a maximum score of 100 points).
Measured: Performed in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Change in rifle disassembling and reassembling from baseline
The protocol for disassembling and reassembling a military-standard issue assault rifle was selected to assess changes in manual dexterity as it is representative tasks that soldiers may encounter in field operations. During the protocol, participants were tasked to disassemble and reassemble a rifle consisting of 8 parts as fast as possible. Prior to the task's onset, standing participants were instructed to place their hands behind their backs and wait for the researcher's "start" command, after which they attempted to disassemble the rifle as quickly as possible. After a two-minute break, during which participants organized the rifle parts on a table, they then proceeded to reassemble the rifle under the same instruction, and the time was recorded. During the reassembling, the final step was conducting a successful "rifle function check". The time for completion of the task was measured using a handheld stopwatch and recorded on a digital camera for possible corrections.
Measured: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Change in countermovement jump height from baseline
We used unloaded countermovement jump (CMJ), one of the most common and straightforward strategies to monitor short-term neuromuscular performance in tactical populations. Each CMJ session included 2 sets (AI and CON in a randomized order) of 3 maximal effort CMJs with 2 min of inter-set standing rest. The researcher verbally instructed and encouraged the participants to jump as high as possible on each jump. All CMJs were performed with wooden dowel (~ 0.5 kg) as a mock barbell placed across the participant's upper back mimicking a regular back squat. A linear position transducer (GymAware Power Tool; Kinetic Performance Technologies, Canberra, Australia) was attached to both sides of a dowel to measure the performance. The depth of the CMJ depth was self-selected. Participants wore the same sports t-shirts, shorts and shoes during each test period. The mean of the 3 jump heights (cm) was calculated for each condition at each test session.
Measured: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Change in heart rate from baseline
All participants wore a chest strap heart rate monitor (Polar Electro Inc., Model H10, Lake Success, NY, USA) during the shooting protocol. Baseline heart rate data were derived as a mean of heart rate from 2 minutes immediately preceding the start of the shooting trial. Heart rate (bpm) was then continuously monitored during all sessions of shooting protocol. After baseline testing, heart rate data were averaged in 15 seconds bins (0-15, 15-30, 30-45, 45-60) for one minute immediately following the AI and CON trials. The mean of these bins from each trial was used in subsequent analysis.
Measured: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Change in rating of perceived exertion from baseline
The rating of perceived exertion (RPE) was recorded during the CMJ testing using a CR-10 scale to evaluate RPE scores after each set of CMJ. RPE is a frequently used marker of exercise intensity typically used for monitoring during exercise tests to complement other intensity measures.
Measured: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Oct 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Malecek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jan Malecek, Charles University, Czech Republic
- Investigators
- Jan Malecek, Principal investigator, Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868798
- Sponsor's protocol ID
- SleepStudy01
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 36 Hours of Sleep Deprivation on Military-related Tasks: Can Ammonium Inhalants Maintain Performance?
- ClinicalTrials.gov ID
- NCT05868798
- Acronym / sponsor ID
- SleepStudy01
- Conditions
- Sleep Deprivation, Military Activity, Sleep, Cognitive Change, Military Combat Stress Reaction
- Keywords
- cognition, military, sleep deprivation, performance, ammonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jan MalecekUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 22 May 2023 (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 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 (i.e., 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 0.3 mL of AI (composed of 15% of ammonia and 35% of alcohol) (31) was used according to the manufacturer's instructions (Dynarex Corporation, Orangeburg, NY). When the ammonia fumes were released, researcher immediately held the capsule under the participant's 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 1.6 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants performed each individual test without ammonia inhalants. |
| Ammonia inhalants | Experimental | Drug: Ammonia InhalantParticipants performed each individual test with ammonia inhalants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- passed an annual physical fitness test
- passed medical checkup within the last year
- have at least two years of active-duty service experience
- report a high level of comfort handling firearms
- non-smokers
Key exclusion criteria (4 listed)
- smoker
- did not pass an annual physical fitness test
- did not pass medical checkup within the last year
- work in Shift-work
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 |
|---|---|---|
| Ammonia InhalantAlso: smelling saltFor all AI trials, a capsule containing 0.3 mL of AI (composed of 15% of ammonia and 35% of alcohol) was used according to the manufacturer's instructions (Dynarex Corporation, Orangeburg, NY). When the ammonia fumes were released, researcher immediately held the capsule under the participant's nose to inhale until a voluntary withdrawal reflex was observed. | Drug | Ammonia inhalants |
Primary outcome
Change in Epworth sleepiness scale from baseline
Time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
We used Epworth Sleepiness Scale (ESS) translated into Czech. It is a self-administered eight-item questionnaire and takes two to three minutes to complete. The questionnaire presents daily lifestyle activities (i.e. reading, watching TV etc.) and participants rate their current self-perceived likelihood of dozing off in each situation, from: "would never doze" (0) to "high chance of dozing". The ESS provides a cumulative score between 0 and 24, with higher numbers indicating greater sleepiness.
Change in simple reaction time from baseline
Time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
A simple reaction time test was used to assess the speed of responses to visual stimuli. The evaluation of reaction time was performed using the PEBL Version 2.0 software. The test consists of instantaneous responses to a visual stimulus by pressing a spacebar key on a laptop's keyboard as quickly as possible when a visual stimulus appears. In the test, 50 trials of stimuli were presented with an interstimulus interval that randomly varied between 250 ms and 2500 ms. Each participant completed four tests (each time two, either with AI or CON, in randomized order) with 2 minutes of inter-test rest. The simple reaction time data obtained were inspected according to pre-determined criteria, which excluded trial executions that were deemed incorrect due to a reaction time shorter than 150 ms or longer than 3000 ms. The mean reaction time (measured in milliseconds) and the number of incorrect trial executions were used as the variables in the subsequent statistical analysis.
Change in handgun shooting accuracy from baseline
Time frame: Performed in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
A laser-based simulator system with an infrared laser handgun was used to assess handgun shooting accuracy. All trials were performed in the standardized isosceles high-ready stance position. For this study, a real-weight mock-up of the Czech military standard issue Glock 17/22 handgun was used (all participants were familiar with the handgun from their active service). Participants wore over-ear headphones during all testing procedures to hear the software command to start shooting and the simulated shooting blasts when pulling the trigger. A 20 cm circular target was placed on a blank wall 4 meters in front of the participants to simulate a standard-issue 50 cm target 10 meters away for the laser-based handgun shooting protocols. For the testing, participants fired 10 shots, aiming to hit the middle of the circular target (a bullseye hit was worth 10 points, and 1 point was deducted for every 1 cm region away from the bullseye, resulting in a maximum score of 100 points).
Change in rifle disassembling and reassembling from baseline
Time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
The protocol for disassembling and reassembling a military-standard issue assault rifle was selected to assess changes in manual dexterity as it is representative tasks that soldiers may encounter in field operations. During the protocol, participants were tasked to disassemble and reassemble a rifle consisting of 8 parts as fast as possible. Prior to the task's onset, standing participants were instructed to place their hands behind their backs and wait for the researcher's "start" command, after which they attempted to disassemble the rifle as quickly as possible. After a two-minute break, during which participants organized the rifle parts on a table, they then proceeded to reassemble the rifle under the same instruction, and the time was recorded. During the reassembling, the final step was conducting a successful "rifle function check". The time for completion of the task was measured using a handheld stopwatch and recorded on a digital camera for possible corrections.
Change in countermovement jump height from baseline
Time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
We used unloaded countermovement jump (CMJ), one of the most common and straightforward strategies to monitor short-term neuromuscular performance in tactical populations. Each CMJ session included 2 sets (AI and CON in a randomized order) of 3 maximal effort CMJs with 2 min of inter-set standing rest. The researcher verbally instructed and encouraged the participants to jump as high as possible on each jump. All CMJs were performed with wooden dowel (~ 0.5 kg) as a mock barbell placed across the participant's upper back mimicking a regular back squat. A linear position transducer (GymAware Power Tool; Kinetic Performance Technologies, Canberra, Australia) was attached to both sides of a dowel to measure the performance. The depth of the CMJ depth was self-selected. Participants wore the same sports t-shirts, shorts and shoes during each test period. The mean of the 3 jump heights (cm) was calculated for each condition at each test session.
Change in heart rate from baseline
Time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
All participants wore a chest strap heart rate monitor (Polar Electro Inc., Model H10, Lake Success, NY, USA) during the shooting protocol. Baseline heart rate data were derived as a mean of heart rate from 2 minutes immediately preceding the start of the shooting trial. Heart rate (bpm) was then continuously monitored during all sessions of shooting protocol. After baseline testing, heart rate data were averaged in 15 seconds bins (0-15, 15-30, 30-45, 45-60) for one minute immediately following the AI and CON trials. The mean of these bins from each trial was used in subsequent analysis.
Change in rating of perceived exertion from baseline
Time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.
The rating of perceived exertion (RPE) was recorded during the CMJ testing using a CR-10 scale to evaluate RPE scores after each set of CMJ. RPE is a frequently used marker of exercise intensity typically used for monitoring during exercise tests to complement other intensity measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: Yes. there is a plan to make IPD and related data dictionaries available.
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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.
Jan Malecek principal investigator
Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ammonia Inhalant in people with Sleep Deprivation and Military Activity, run by Jan Malecek at 1 site in Czechia.
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 7 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: finished, as of the sponsor's last update on 22 May 2023. 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 Czechia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Epworth sleepiness scale from baseline (time frame: We were following changes in 5 identical testing sessions during 36 hours of total sleep deprivation (after 0-baseline, 12, 24, and 36 hours), and after 8 hours of recovery sleep.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.