Hypohidrotic Ectodermal DysplasiaDEH-SomnoNCT05378932
Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia
A study testing Actigraphy, Recording of proximal and distal skin temperature and temperature of the bedroom and Questionnaires assessing subjective sleep quality in people with Hypohidrotic Ectodermal Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to compare sleep efficiency by means of actigraphy in patients with hypohidrotic ectodermal dysplasia with healthy controls. Sleep efficiency, assessed on actigraphy, sleep architecture assessed on on polysomnography, body temperature and urine melatonin levels will be compared between the… Read more about this study
- Who is it for?
- Ages 3 to 40 years, men only
- Conditions the study is for
- Hypohidrotic Ectodermal Dysplasia
- What is being tested?
- Actigraphy, Recording of proximal and distal skin temperature and temperature of the bedroom and Questionnaires assessing subjective sleep quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2022to 16 Jan 2024
- Phase
- Interventional
- 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 3 to 40 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male patients with molecularly confirmed hypohidrotic ectodermal dysplasia (HED), children over 3 years of age and adults under 40 years of age. Patients will be separated into 3 age groups (3 to 6 years old, 7 to 12 years old, 13 years old and over)
- Healthy controls (control subjects), of same age group, recruited if possible within the patient's direct entourage
- Written informed consent
Who cannot join
- No social insurance
- Presence of an associated pathology known to alter the quality of sleep (neurological, cardiac, psychiatric, severe sleep apnea syndrome)
- Presence of an associated pathology causing significant psychomotor retardation, behavioral disorders with impossible cooperation or significant agitation
- Treatment with psychotropic drugs or drugs stimulating vigilance
- Patient under guardianship/curatorship
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare sleep efficiency by means of actigraphy in patients with hypohidrotic ectodermal dysplasia with healthy controls.
Sleep efficiency, assessed on actigraphy, sleep architecture assessed on on polysomnography, body temperature and urine melatonin levels will be compared between the patients with hypohidrotic ectodermal dysplasia with healthy controls.
Read the detailed description
Ectodermal dysplasias (ED) are rare genetic diseases characterized by a developmental abnormality of at least two of the following ectodermal derivatives: teeth, nails, pilosity and glands. In the hypohidrotic form (HED), dental abnormalities (oligodontia, hypodontia) and the decrease or even the absence of sweating are predominant. The lack of sweating, and therefore of the regulation of core body temperature, can impact the daily lives of patients as soon as the ambient temperature exceeds 23-24 ° C.
Core body temperature is one of the players of the internal biological clock that regulates sleep. Indeed, sleep is induced by a decrease in core body temperature concomitant with a peak of melatonin secretion. Consequently, the absence of sweating in HED and therefore the inability to lower core body temperature may explain the poor sleep quality reported by patients. However, sleep disturbances have not been analyzed in the literature nor the relationship between sleep quality and core body temperature in patients with HED.
The sleep of patients with HED who are followed at the national reference center for rare diseases of the skin and mucous membranes of genetic origin (MAGEC center) of the Necker-Enfants Malades hospital will be evaluated and compared to sleep of healthy controls screened within in the patient's family.
The main objective of the study is to compare the sleep efficiency evaluated on actigraphy between HED patients and healthy controls.
Sleep efficiency will be measured by means of actigraphy during 10 days and one overnight polysomnography, together with continuous recording of proximal and distal skin temperature during 10 days, one-off measurement of sweating by a sweat test and urine melatonin assay over 24 hours.
Subjective sleep quality will also be assessed by means of questionnaires in patients and healthy controls. Finally, patients with HED will also have a standardized psychological and neuropsychological assessment.
- Conditions
- Hypohidrotic Ectodermal Dysplasia
- Being tested
- Actigraphy, Recording of proximal and distal skin temperature and temperature of the bedroom, Questionnaires assessing subjective sleep quality, Sweat test, Urine melatonin assay
- Keywords
- Hypohidrotic ectodermal dysplasia, Sleep efficiency, Circadian biological clock, Melatonin, Actigraphy, Polysomnography (PSG)
- Medical subject headings
- Ectodermal Dysplasia 1, Anhidrotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyOther
Sleep efficiency recording at home by means of actigraphy during 10 consecutive days.
Recording of proximal and distal skin temperature and temperature of the bedroomOther
Recording of proximal and distal skin temperature at home by data loggers placed on the skin during 10 consecutive days.
Recording of temperature of the bedroom by a data logger during 10 consecutive days.
Questionnaires assessing subjective sleep qualityOther
One-off questionnaires assessing subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) evaluates sleep quality with questions about sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction during the last month.
The Epworth Sleepiness Scale evaluates daytime sleepiness and comprises 8 items (situations) during which individuals assess how likely they would fall asleep.
Sweat testOther
One-off measurement of sweating by a sweat test at the hospital.
Urine melatonin assayOther
Two urine melatonin at home during 24 hours, one during a week day and one during the weekend
PolysomnographyOther
Sleep architecture assessed by a polysomnography during one night at home.
Standardized psychological and neuropsychological assessmentOther
One-off psychological and neuropsychological assessment of patients with HED during a hospital visit
| Study group | Role | What they receive |
|---|---|---|
| Hypohidrotic ectodermal dysplasia | Experimental | Patients aged 3 to 40 years old with hypohidrotic ectodermal dysplasia. Receives: Other: Actigraphy; Other: Recording of proximal and distal skin temperature and temperature of the bedroom; Other: Questionnaires assessing subjective sleep quality; Other: Sweat test; Other: Urine melatonin assay; Other: Polysomnography; Other: Standardized psychological and neuropsychological assessment |
| Healthy controls | Active comparator | Healthy controls aged 3 to 40 years old without hypohidrotic ectodermal dysplasia. Receives: Other: Actigraphy; Other: Recording of proximal and distal skin temperature and temperature of the bedroom; Other: Questionnaires assessing subjective sleep quality; Other: Sweat test; Other: Urine melatonin assay; Other: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency on actigraphy
Comparison of sleep efficiency evaluated on actigraphy between HED patients and healthy controls.
Measured: 10 days
Total sleep time on actigraphy
Comparison of total sleep time evaluated on actigraphy between HED patients and healthy controls.
Measured: 10 days
Awake after sleep onset on actigraphy
Comparison of wake after sleep onset evaluated on actigraphy between HED patients and healthy controls.
Measured: 10 days
Sleep fragmentation index
Comparison of sleep fragmentation index evaluated on actigraphy between HED patients and healthy controls.
Measured: 10 days
Secondary outcomes (23)
Melatonin secretion cycle
Comparison of the melatonin secretion cycle between DEH patients and healthy controls using the urinary quantitative assay of 6-sulfatoxymelatonin by ELISA method.
Measured: 48 hours
Total sleep time on polysomnography
Comparison of total sleep time evaluated on polysomnography between HED patients and healthy controls.
Measured: One night
Sleep onset latency
Comparison of sleep onset latency evaluated on polysomnography between HED patients and healthy controls.
Measured: One night
Sleep efficiency on polysomnography
Comparison of sleep efficiency evaluated on polysomnography between HED patients and healthy controls.
Measured: One night
Awake after sleep onset on polysomnography
Comparison of wake after sleep onset evaluated on polysomnography between HED patients and healthy controls.
Measured: One night
Micro-arousal index
Comparison of micro-arousal index evaluated on polysomnography between HED patients and healthy controls.
Measured: One night
Percentage of sleep stages
Comparison of the percentage of sleep stages evaluated on polysomnography between HED patients and healthy controls.
Measured: One night
Pittsburgh Sleep Quality Index
Subjective sleep quality. Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality. Normal value <5.
The Epworth Sleepiness Scale to assess daytime sleepiness (normal value <8)
Measured: Day 0
Epworth Sleepiness Scale
Subjective sleep quality. The Epworth Sleepiness Scale to assess daytime sleepiness. Normal value <8.
The Epworth Sleepiness Scale to assess daytime sleepiness (normal value <8)
Measured: Day 0
WPPSI-IV intellectual ability test
Neuropsychologic tests in patients with hypohidrotic ectodermal dysplasia using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score <70.
Measured: Day 0
WISC-V intellectual ability tests
Neuropsychologic tests in patients with hypohidrotic ectodermal dysplasia using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score <70.
Measured: Day 0
WAIS-IV intellectual ability tests
Neuropsychologic tests in patients with hypohidrotic ectodermal dysplasia using the WAIS-IV. Mean normal score is 100 ± 15. Abnormal for a score <70.
Measured: Day 0
TAP attention test
Attention test in patients with hypohidrotic ectodermal dysplasia using the TAP test. Mean normal value of T-score is 50 ± 1. Abnormal for a T-score <30.
Measured: Day 0
NEPSY-II attention test
Attention test in patients with hypohidrotic ectodermal dysplasia using the NEPSY-II test. Mean normal value =10 (SD3). Abnormal for a score <4).
Measured: Day 0
Conners 3 attention questionnaire
Attention questionnaire in patients with hypohidrotic ectodermal dysplasia using Conners 3 questionnaire. Mean normal value of T-score is 50 ± 10), abnormal T-score > 69.
Measured: Day 0
NEPSY-II for executive function test
Executive function evaluation in patients with hypohidrotic ectodermal dysplasia using the NEPSY-II Mean normal score is 10 ± 3, abnormal when score <4.
Measured: Day 0
Trail Making for executive function test
Executive function evaluation in patients with hypohidrotic ectodermal dysplasia using the Trail Making test. Mean normal score is 10 ± 3, abnormal when score <4.
Measured: Day 0
TAP subtests for executive function
Executive function evaluation in patients with hypohidrotic ectodermal dysplasia using the TAP subtests. Mean normal value of T-score TAP subtests is 50 ± 10, abnormal T-score is <30.
Measured: Day 0
BRIEF and BRIEF-P questionnaire for executive function
Executive function questionnaire in patients with hypohidrotic ectodermal dysplasia using BRIEF and BRIEF-P questionnaire. Mean normal value of T-score is 50 ± 10, abnormal T-score is > 65.
Measured: Day 0
Correlation between skin temperature and sleep efficiency and architecture
Correlation between skin temperature and sleep efficiency in patients with hypohidrotic ectodermal dysplasia and healthy controls.
Sleep efficiency is evaluated by actigraphy results and architecture by polysomnography results.
Skin temperature is evaluated by a data logger placed on the skin.
Measured: 10 days
Correlation between skin temperature and sleep questionnaires scores
Correlation between skin temperature and sleep quality questionnaires scores in patients with hypohidrotic ectodermal dysplasia and healthy controls.
Measured: 10 days
Correlation between skin temperature and melatonin secretion
Correlation between skin temperature and melatonin secretion cycle in patients with hypohidrotic ectodermal dysplasia and in control subjects.
Measured: 10 days
Correlation between sleep efficiency and neuropsychological test scores
Correlation between sleep efficiency evaluated on actigraphy and neuropsychological test scores in patients with hypohidrotic ectodermal dysplasia.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start10 Jun 2022
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypohidrotic Ectodermal DysplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lucie Griffon, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisBrigitte Fauroux, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisSmail Hadj-Rabia, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378932
- Sponsor's protocol ID
- APHP220045
- Other IDs
- 2021-A02736-35
- Acronym
- DEH-Somno
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia
- ClinicalTrials.gov ID
- NCT05378932
- Acronym / sponsor ID
- DEH-Somno / APHP220045
- Conditions
- Hypohidrotic Ectodermal Dysplasia
- Keywords
- Hypohidrotic ectodermal dysplasia, Sleep efficiency, Circadian biological clock, Melatonin, Actigraphy, Polysomnography (PSG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 18 May 2022 (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.
The aim of the study is to compare sleep efficiency by means of actigraphy in patients with hypohidrotic ectodermal dysplasia with healthy controls.
Sleep efficiency, assessed on actigraphy, sleep architecture assessed on on polysomnography, body temperature and urine melatonin levels will be compared between the patients with hypohidrotic ectodermal dysplasia with healthy controls.
Detailed description
Ectodermal dysplasias (ED) are rare genetic diseases characterized by a developmental abnormality of at least two of the following ectodermal derivatives: teeth, nails, pilosity and glands. In the hypohidrotic form (HED), dental abnormalities (oligodontia, hypodontia) and the decrease or even the absence of sweating are predominant. The lack of sweating, and therefore of the regulation of core body temperature, can impact the daily lives of patients as soon as the ambient temperature exceeds 23-24 ° C.
Core body temperature is one of the players of the internal biological clock that regulates sleep. Indeed, sleep is induced by a decrease in core body temperature concomitant with a peak of melatonin secretion. Consequently, the absence of sweating in HED and therefore the inability to lower core body temperature may explain the poor sleep quality reported by patients. However, sleep disturbances have not been analyzed in the literature nor the relationship between sleep quality and core body temperature in patients with HED.
The sleep of patients with HED who are followed at the national reference center for rare diseases of the skin and mucous membranes of genetic origin (MAGEC center) of the Necker-Enfants Malades hospital will be evaluated and compared to sleep of healthy controls screened within in the patient's family.
The main objective of the study is to compare the sleep efficiency evaluated on actigraphy between HED patients and healthy controls.
Sleep efficiency will be measured by means of actigraphy during 10 days and one overnight polysomnography, together with continuous recording of proximal and distal skin temperature during 10 days, one-off measurement of sweating by a sweat test and urine melatonin assay over 24 hours.
Subjective sleep quality will also be assessed by means of questionnaires in patients and healthy controls. Finally, patients with HED will also have a standardized psychological and neuropsychological assessment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypohidrotic ectodermal dysplasia | Experimental | Other: Actigraphy, Other: Recording of proximal and distal skin temperature and temperature of the bedroom, Other: Questionnaires assessing subjective sleep quality, Other: Sweat test, Other: Urine melatonin assay, Other: Polysomnography, Other: Standardized psychological and neuropsychological assessmentPatients aged 3 to 40 years old with hypohidrotic ectodermal dysplasia. |
| Healthy controls | Active comparator | Other: Actigraphy, Other: Recording of proximal and distal skin temperature and temperature of the bedroom, Other: Questionnaires assessing subjective sleep quality, Other: Sweat test, Other: Urine melatonin assay, Other: PolysomnographyHealthy controls aged 3 to 40 years old without hypohidrotic ectodermal dysplasia. |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male patients with molecularly confirmed hypohidrotic ectodermal dysplasia (HED), children over 3 years of age and adults under 40 years of age. Patients will be separated into 3 age groups (3 to 6 years old, 7 to 12 years old, 13 years old and over)
- Healthy controls (control subjects), of same age group, recruited if possible within the patient's direct entourage
- Written informed consent
Key exclusion criteria (5 listed)
- No social insurance
- Presence of an associated pathology known to alter the quality of sleep (neurological, cardiac, psychiatric, severe sleep apnea syndrome)
- Presence of an associated pathology causing significant psychomotor retardation, behavioral disorders with impossible cooperation or significant agitation
- Treatment with psychotropic drugs or drugs stimulating vigilance
- Patient under guardianship/curatorship
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 |
|---|---|---|
| ActigraphySleep efficiency recording at home by means of actigraphy during 10 consecutive days. | Other | Healthy controls, Hypohidrotic ectodermal dysplasia |
| Recording of proximal and distal skin temperature and temperature of the bedroomRecording of proximal and distal skin temperature at home by data loggers placed on the skin during 10 consecutive days. Recording of temperature of the bedroom by a data logger during 10 consecutive days. | Other | Healthy controls, Hypohidrotic ectodermal dysplasia |
| Questionnaires assessing subjective sleep qualityOne-off questionnaires assessing subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) evaluates sleep quality with questions about sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction during the last month. The Epworth Sleepiness Scale evaluates daytime sleepiness and comprises 8 items (situations) during which individuals assess how likely they would fall asleep. | Other | Healthy controls, Hypohidrotic ectodermal dysplasia |
| Sweat testOne-off measurement of sweating by a sweat test at the hospital. | Other | Healthy controls, Hypohidrotic ectodermal dysplasia |
| Urine melatonin assayTwo urine melatonin at home during 24 hours, one during a week day and one during the weekend | Other | Healthy controls, Hypohidrotic ectodermal dysplasia |
| PolysomnographySleep architecture assessed by a polysomnography during one night at home. | Other | Healthy controls, Hypohidrotic ectodermal dysplasia |
| Standardized psychological and neuropsychological assessmentOne-off psychological and neuropsychological assessment of patients with HED during a hospital visit | Other | Hypohidrotic ectodermal dysplasia |
Primary outcome
Sleep efficiency on actigraphy
Time frame: 10 days
Comparison of sleep efficiency evaluated on actigraphy between HED patients and healthy controls.
Total sleep time on actigraphy
Time frame: 10 days
Comparison of total sleep time evaluated on actigraphy between HED patients and healthy controls.
Awake after sleep onset on actigraphy
Time frame: 10 days
Comparison of wake after sleep onset evaluated on actigraphy between HED patients and healthy controls.
Sleep fragmentation index
Time frame: 10 days
Comparison of sleep fragmentation index evaluated on actigraphy between HED patients and healthy controls.
23 secondary outcomes
Melatonin secretion cycle
Time frame: 48 hours
Total sleep time on polysomnography
Time frame: One night
Sleep onset latency
Time frame: One night
Sleep efficiency on polysomnography
Time frame: One night
Awake after sleep onset on polysomnography
Time frame: One night
Micro-arousal index
Time frame: One night
Percentage of sleep stages
Time frame: One night
Pittsburgh Sleep Quality Index
Time frame: Day 0
Epworth Sleepiness Scale
Time frame: Day 0
WPPSI-IV intellectual ability test
Time frame: Day 0
WISC-V intellectual ability tests
Time frame: Day 0
WAIS-IV intellectual ability tests
Time frame: Day 0
TAP attention test
Time frame: Day 0
NEPSY-II attention test
Time frame: Day 0
Conners 3 attention questionnaire
Time frame: Day 0
NEPSY-II for executive function test
Time frame: Day 0
Trail Making for executive function test
Time frame: Day 0
TAP subtests for executive function
Time frame: Day 0
BRIEF and BRIEF-P questionnaire for executive function
Time frame: Day 0
Correlation between skin temperature and sleep efficiency and architecture
Time frame: 10 days
Correlation between skin temperature and sleep questionnaires scores
Time frame: 10 days
Correlation between skin temperature and melatonin secretion
Time frame: 10 days
Correlation between sleep efficiency and neuropsychological test scores
Time frame: 10 days
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 12 Sep 2025.
- 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.
Lucie Griffon, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Brigitte Fauroux, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Smail Hadj-Rabia, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphy, Recording of proximal and distal skin temperature and temperature of the bedroom and Questionnaires assessing subjective sleep quality in people with Hypohidrotic Ectodermal Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 5 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 12 Sep 2025. 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 France. 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?
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?
Sleep efficiency on actigraphy (time frame: 10 days). The study lists 4 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 12 Sep 2025.