SensitivitySensoryFLONCT03283072
Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
A study testing Intervention 1, Intervention 2 and Intervention 3 in people with Sensitivity, run by University of Florida at 1 site in United States.
Trial summary
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity
- What is being tested?
- Intervention 1, Intervention 2 and Intervention 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 40 years of age
Who cannot join
- Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery disease, congenital and valvar heart diseases)
- Diagnosis of neuromuscular disease
- Diagnosis of any neurological disease
- Presence of concurrent medical illness including infection, fractures
- Diagnosis of obstructive sleep apnea
- Diagnosis of obstructive/restrictive lung disease
Show all 16Show fewer
- Diagnosis of exercise induced asthma
- FEV1/FVC<80% and/or FVC<80% of predicted value indicating airway obstruction
- Subjects on prednisolone therapy or selective serotonin reuptake inhibitor (SSRI) therapy will be excluded from the study as these pharmacological agents are known to amplify the effects of IH[22, 23]
- Diagnosis of epilepsy or history of seizures and attention deficit disorders
- Pregnancy
- Diabetes
- History of coagulation disorders
- History of chronic pain
- Body mass index(BMI)> 35kg/m2
- Subjects on prescription medicines such as beta blockers and other drugs that are prescribed in any of the exclusionary disorders listed above.
Trial locations and contacts
1 site in 1 country.
About this study
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported.
Read the detailed description
Despite the strong results of motor studies, the affects of AIH on sensory function has not been established. We will use a commercially-available hypoxicator that can be programmed to achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously published protocols that have generated motor facilitation (and a sham condition) to characterize and effects on sensory function in healthy adults.
- Conditions
- Sensitivity
- Being tested
- Intervention 1, Intervention 2, Intervention 3, Intervention 4 (sham)
- Keywords
- thermal threshold, pressure pain threshold, temporal summation
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Device
15 bouts of 2mins:1min hypoxia:hyperoxia
Intervention 2Device
15 bouts of 1mins:1min hypoxia:hyperoxia
Intervention 3Device
8 bouts of 2mins:1min hypoxia:hyperoxia
Intervention 4 (sham)Device
15 bouts of 1min:1min normoxia
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Receives: Device: Intervention 1; Device: Intervention 2; Device: Intervention 3; Device: Intervention 4 (sham) |
| Sequence 2 | Experimental | Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Receives: Device: Intervention 1; Device: Intervention 2; Device: Intervention 3; Device: Intervention 4 (sham) |
| Sequence 3 | Experimental | Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Receives: Device: Intervention 1; Device: Intervention 2; Device: Intervention 3; Device: Intervention 4 (sham) |
| Sequence 4 | Experimental | 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia Receives: Device: Intervention 1; Device: Intervention 2; Device: Intervention 3; Device: Intervention 4 (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Function
Thermal thresholds. Average reported.
Measured: Every 10 minutes for 60 minutes post intervention, average reported
Temporal Sensory Summation
Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
Measured: Every 10 minutes for 60 minutes post intervention, average reported
Sensory Function - Pressure
Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
Measured: Every 10 minutes for 60 minutes post intervention, average reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start18 Sep 2017
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SensitivityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark D Bishop, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283072
- Sponsor's protocol ID
- IRB201700637
- Acronym
- SensoryFLO
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2017
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
- ClinicalTrials.gov ID
- NCT03283072
- Acronym / sponsor ID
- SensoryFLO / IRB201700637
- Conditions
- Sensitivity
- Keywords
- thermal threshold, pressure pain threshold, temporal summation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported.
Detailed description
Despite the strong results of motor studies, the affects of AIH on sensory function has not been established. We will use a commercially-available hypoxicator that can be programmed to achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously published protocols that have generated motor facilitation (and a sham condition) to characterize and effects on sensory function in healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: Intervention 1, Device: Intervention 2, Device: Intervention 3, Device: Intervention 4 (sham)Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) |
| Sequence 2 | Experimental | Device: Intervention 1, Device: Intervention 2, Device: Intervention 3, Device: Intervention 4 (sham)Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia |
| Sequence 3 | Experimental | Device: Intervention 1, Device: Intervention 2, Device: Intervention 3, Device: Intervention 4 (sham)Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia |
| Sequence 4 | Experimental | Device: Intervention 1, Device: Intervention 2, Device: Intervention 3, Device: Intervention 4 (sham)15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 to 40 years of age
Key exclusion criteria (16 listed)
- Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery disease, congenital and valvar heart diseases)
- Diagnosis of neuromuscular disease
- Diagnosis of any neurological disease
- Presence of concurrent medical illness including infection, fractures
- Diagnosis of obstructive sleep apnea
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 |
|---|---|---|
| Intervention 115 bouts of 2mins:1min hypoxia:hyperoxia | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Intervention 215 bouts of 1mins:1min hypoxia:hyperoxia | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Intervention 38 bouts of 2mins:1min hypoxia:hyperoxia | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Intervention 4 (sham)15 bouts of 1min:1min normoxia | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Sensory Function
Time frame: Every 10 minutes for 60 minutes post intervention, average reported
Thermal thresholds. Average reported.
Temporal Sensory Summation
Time frame: Every 10 minutes for 60 minutes post intervention, average reported
Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
Sensory Function - Pressure
Time frame: Every 10 minutes for 60 minutes post intervention, average reported
Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mark D Bishop, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1, Intervention 2 and Intervention 3 in people with Sensitivity, run by University of Florida at 1 site in United States.
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 1 inclusion and 16 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 21 Aug 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensory Function (time frame: Every 10 minutes for 60 minutes post intervention, average reported). The study lists 3 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 21 Aug 2023.