Sleep DisruptionSHIRNCT07639229
Sleep Hygiene During Ramadan
A study testing Culturally Adapted Sleep Hygiene Education Program in people with Sleep Disruption and Sleep Hygiene, run by The Higher Institute of Sport and Physical Education of Sfax at 1 site in Tunisia.
Trial summary
Ramadan fasting often disrupts sleep patterns, which can affect alertness and physical performance in student-athletes. This study tested whether a brief sleep education program designed for Ramadan could help improve sleep quality and maintain performance. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disruption, Sleep Hygiene, Ramadan Fasting
- What is being tested?
- Culturally Adapted Sleep Hygiene Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Feb 2025to 31 Mar 2025
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sports science students aged 18 to 30 years
- Intend to fast for the full duration of Ramadan
- No history of diagnosed sleep disorders or medical conditions affecting sleep or cognition
- Free from musculoskeletal injuries that could limit physical performance tests
Who cannot join
- Chronic sleep disorders (e.g., insomnia, obstructive sleep apnea)
- Use of medications known to affect sleep or alertness
- Failure to complete the Ramadan fasting period
- Non-compliance with actigraphy monitoring procedures
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Higher Institute of Sport and Physical Education of Sfax (ISSEP Sfax)
Sfax, Sfax Governorate, 3000
About this study
Official title: Effects of a Culturally Adapted Sleep Hygiene Intervention on Sleep, Vigilance, and Physical Performance During Ramadan in Male Sports Science Students: A Randomized Controlled Trial
Ramadan fasting often disrupts sleep patterns, which can affect alertness and physical performance in student-athletes. This study tested whether a brief sleep education program designed for Ramadan could help improve sleep quality and maintain performance.
Sixty-four male sport-science students who planned to fast during Ramadan were randomly assigned to one of two groups. The first group received a 45-minute educational session about sleep hygiene specifically adapted to Ramadan practices (timing of sleep around evening and pre-dawn meals, managing light exposure, limiting caffeine and screen time before bed). They also received weekly text message reminders and completed short weekly checklists about their sleep habits. The second group continued their usual routines without any intervention.
Read more
Participants wore activity monitors on their wrist to track sleep throughout the study. They also completed computerized tests of attention and reaction time, as well as physical performance tests (jumping, handgrip strength, agility) before Ramadan and during the final week of fasting.
The researchers found that students who received the sleep education maintained better sleep duration and quality during Ramadan compared to those who did not receive the program. They also showed better attention, faster reaction times, and better preservation of physical performance. This suggests that simple, culturally-adapted sleep education can help student-athletes maintain their health and performance during Ramadan.
Read the detailed description
This pilot randomized controlled trial investigated the effects of a culturally adapted sleep hygiene education program on objectively measured sleep, psychomotor vigilance, and physical performance during Ramadan in male sport-science students.
STUDY DESIGN AND PARTICIPANTS:
Sixty-four male sport-science students (aged 18-30 years) from the Higher Institute of Sport and Physical Education of Sfax, Tunisia, who intended to observe Ramadan fasting, were randomly allocated to either an intervention group (n=32) or a control group (n=32). Randomization was performed using computer-generated block randomization with allocation concealment via sealed envelopes.
INTERVENTION:
Participants in the intervention group received a single 45-minute educational session during the week preceding Ramadan. The session addressed sleep hygiene strategies specifically adapted to Ramadan constraints, including: (1) maintaining consistent sleep schedules compatible with suhoor (pre-dawn meal) and iftar (evening meal) timing, (2) managing evening light exposure and screen use, (3) regulating caffeine intake, (4) optimizing the sleep environment, and (5) planning sleep consolidation strategies. Participants received written educational materials and weekly text message reminders (Monday and Thursday) throughout Ramadan. Adherence was monitored using weekly self-report checklists returned each Saturday. The control group received no intervention and maintained their usual daily habits.
OUTCOME MEASURES:
Primary outcomes were sleep parameters assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline (approximately 2 weeks before Ramadan) through week 4 of Ramadan. Derived parameters included total sleep time, sleep efficiency, and wake after sleep onset (WASO). A minimum of 5 valid nights was required for analysis.
Secondary outcomes assessed at baseline and Ramadan week 4 included:
- Psychomotor vigilance: 10-minute Psychomotor Vigilance Test (PVT) measuring mean reaction time and number of lapses (reaction times >500 ms)
- Neuromuscular performance: countermovement jump (CMJ), squat jump (SJ), handgrip strength, and agility (change-of-direction test)
COVARIATES:
Baseline values of all outcome variables were included as covariates. Additional covariates assessed at baseline included chronotype (reduced Morningness-Eveningness Questionnaire), daily caffeine intake (cups/day), and evening screen exposure (minutes in the last hour before bedtime).
STATISTICAL ANALYSIS:
Changes in sleep parameters were analyzed using linear mixed-effects models with group, time, and group × time interaction as fixed effects, and participant as a random effect. Baseline values were included as covariates. For cognitive and physical performance outcomes at week 4, analysis of covariance (ANCOVA) was used with group as the fixed factor and baseline values as covariates. Effect sizes were reported as partial eta squared (η²p) for ANCOVA models and Hedges' g for adjusted between-group comparisons. Statistical significance was set at p < 0.05.
STUDY PERIOD:
Data collection occurred from February 10, 2025 (baseline) to March 31, 2025 (end of Ramadan 1446 AH, corresponding to March 1-30, 2025 in Tunisia).
ETHICAL CONSIDERATIONS:
The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. The protocol was reviewed by the Institutional Scientific Committee of ISSEPS Sfax and determined to be exempt from formal external ethics committee review under Tunisian regulations governing minimal-risk behavioral research.
This trial was registered retrospectively at ClinicalTrials.gov.
- Conditions
- Sleep Disruption, Sleep Hygiene, Ramadan Fasting
- Being tested
- Culturally Adapted Sleep Hygiene Education Program
- Keywords
- Ramadan, Sleep hygiene, Psychomotor vigilance, Athletic performance, Sport-science students, Behavioral intervention, Cognitive performance
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Sleep Hygiene Education ProgramBehavioural
A structured educational session addressing sleep scheduling relative to suhoor/iftar, evening light and screen exposure management, caffeine intake regulation, and sleep environment optimization. Delivered as a single 45-minute session before Ramadan, supplemented with written guidelines, weekly self-report checklists, and bi-weekly SMS reminders.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Sleep Hygiene Education) | Experimental | Participants receive a single 45-minute culturally adapted sleep hygiene education session prior to Ramadan, followed by written materials, weekly adherence checklists, and bi-weekly SMS reminders throughout Ramadan. Receives: Behavioral: Culturally Adapted Sleep Hygiene Education Program |
| Control Group | No intervention | Participants receive no sleep hygiene education or reminders and are instructed to maintain their usual daily routines and sleep habits throughout the Ramadan period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Total sleep time in minutes per night, assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline (approximately 2 weeks before Ramadan) through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.
Measured: Baseline and Ramadan week 4
Sleep Efficiency
Sleep efficiency percentage (ratio of total sleep time to time in bed × 100), assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.
Measured: Baseline and Ramadan week 4
Wake After Sleep Onset (WASO)
Wake after sleep onset in minutes per night, assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.
Measured: Baseline and Ramadan week 4
Secondary outcomes (6)
Psychomotor Vigilance - Lapses
Number of lapses (reaction times ≥500 milliseconds) on the 10-minute Psychomotor Vigilance Test (PVT), assessed at baseline and Ramadan week 4.
Measured: Baseline and Ramadan week 4
Countermovement Jump Height
Lower-limb explosive power assessed by countermovement jump (CMJ) height in centimeters. Best performance of 3 maximal trials retained for analysis.
Measured: Baseline and Ramadan week 4
Squat Jump Height
Lower-limb explosive power assessed by squat jump (SJ) height in centimeters. Best performance of 3 maximal trials retained for analysis.
Measured: Baseline and Ramadan week 4
Handgrip Strength
Maximal handgrip strength in kilograms measured using a handgrip dynamometer. Best performance of 3 maximal contractions with dominant hand retained for analysis.
Measured: Baseline and Ramadan week 4
Agility Performance
Change-of-direction agility test performance time in seconds. Best performance of 2 trials retained for analysis.
Measured: Baseline and Ramadan week 4
Psychomotor Vigilance - Mean Reaction Time
Mean reaction time in milliseconds on the 10-minute Psychomotor Vigilance Test (PVT), assessed at baseline and Ramadan week 4 under standardized conditions.
Measured: Baseline and Ramadan week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start10 Feb 2025
- Primary completion30 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisruptionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group pilot randomized controlled trial comparing a culturally adapted sleep hygiene education intervention to a control condition (usual habits). Participants were randomized 1:1 using computer-generated block randomization with allocation concealment via sealed envelopes. Outcome assessors conducting cognitive (PVT) and physical performance tests, as well as data analysts, were blinded to group allocation. Participants and the investigator delivering the educational session were unblinded due to the behavioral nature of the intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Higher Institute of Sport and Physical Education of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kais Elabed, The Higher Institute of Sport and Physical Education of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639229
- Sponsor's protocol ID
- ISSEPS_SleepRamadan_2025
- Acronym
- SHIR
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available. This includes demographic and anthropometric data, objective sleep outcomes derived from actigraphy (total sleep time, sleep efficiency, wake after sleep onset), psychomotor vigilance test (PVT) results (mean reaction time, lapses), and physical performance test results (countermovement jump, squat jump, handgrip strength, and agility).
Publications
Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142.
PubMed 24179309
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Culturally Adapted Sleep Hygiene Intervention on Sleep, Vigilance, and Physical Performance During Ramadan in Male Sports Science Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07639229
- Acronym / sponsor ID
- SHIR / ISSEPS_SleepRamadan_2025
- Conditions
- Sleep Disruption, Sleep Hygiene, Ramadan Fasting
- Keywords
- Ramadan, Sleep hygiene, Psychomotor vigilance, Athletic performance, Sport-science students, Behavioral intervention, Cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Higher Institute of Sport and Physical Education of SfaxUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Jun 2026 (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.
Ramadan fasting often disrupts sleep patterns, which can affect alertness and physical performance in student-athletes. This study tested whether a brief sleep education program designed for Ramadan could help improve sleep quality and maintain performance.
Sixty-four male sport-science students who planned to fast during Ramadan were randomly assigned to one of two groups. The first group received a 45-minute educational session about sleep hygiene specifically adapted to Ramadan practices (timing of sleep around evening and pre-dawn meals, managing light exposure, limiting caffeine and screen time before bed). They also received weekly text message reminders and completed short weekly checklists about their sleep habits. The second group continued their usual routines without any intervention.
Participants wore activity monitors on their wrist to track sleep throughout the study. They also completed computerized tests of attention and reaction time, as well as physical performance tests (jumping, handgrip strength, agility) before Ramadan and during the final week of fasting.
The researchers found that students who received the sleep education maintained better sleep duration and quality during Ramadan compared to those who did not receive the program. They also showed better attention, faster reaction times, and better preservation of physical performance. This suggests that simple, culturally-adapted sleep education can help student-athletes maintain their health and performance during Ramadan.
Detailed description
This pilot randomized controlled trial investigated the effects of a culturally adapted sleep hygiene education program on objectively measured sleep, psychomotor vigilance, and physical performance during Ramadan in male sport-science students.
STUDY DESIGN AND PARTICIPANTS:
Sixty-four male sport-science students (aged 18-30 years) from the Higher Institute of Sport and Physical Education of Sfax, Tunisia, who intended to observe Ramadan fasting, were randomly allocated to either an intervention group (n=32) or a control group (n=32). Randomization was performed using computer-generated block randomization with allocation concealment via sealed envelopes.
INTERVENTION:
Participants in the intervention group received a single 45-minute educational session during the week preceding Ramadan. The session addressed sleep hygiene strategies specifically adapted to Ramadan constraints, including: (1) maintaining consistent sleep schedules compatible with suhoor (pre-dawn meal) and iftar (evening meal) timing, (2) managing evening light exposure and screen use, (3) regulating caffeine intake, (4) optimizing the sleep environment, and (5) planning sleep consolidation strategies. Participants received written educational materials and weekly text message reminders (Monday and Thursday) throughout Ramadan. Adherence was monitored using weekly self-report checklists returned each Saturday. The control group received no intervention and maintained their usual daily habits.
OUTCOME MEASURES:
Primary outcomes were sleep parameters assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline (approximately 2 weeks before Ramadan) through week 4 of Ramadan. Derived parameters included total sleep time, sleep efficiency, and wake after sleep onset (WASO). A minimum of 5 valid nights was required for analysis.
Secondary outcomes assessed at baseline and Ramadan week 4 included:
- Psychomotor vigilance: 10-minute Psychomotor Vigilance Test (PVT) measuring mean reaction time and number of lapses (reaction times >500 ms)
- Neuromuscular performance: countermovement jump (CMJ), squat jump (SJ), handgrip strength, and agility (change-of-direction test)
COVARIATES:
Baseline values of all outcome variables were included as covariates. Additional covariates assessed at baseline included chronotype (reduced Morningness-Eveningness Questionnaire), daily caffeine intake (cups/day), and evening screen exposure (minutes in the last hour before bedtime).
STATISTICAL ANALYSIS:
Changes in sleep parameters were analyzed using linear mixed-effects models with group, time, and group × time interaction as fixed effects, and participant as a random effect. Baseline values were included as covariates. For cognitive and physical performance outcomes at week 4, analysis of covariance (ANCOVA) was used with group as the fixed factor and baseline values as covariates. Effect sizes were reported as partial eta squared (η²p) for ANCOVA models and Hedges' g for adjusted between-group comparisons. Statistical significance was set at p < 0.05.
STUDY PERIOD:
Data collection occurred from February 10, 2025 (baseline) to March 31, 2025 (end of Ramadan 1446 AH, corresponding to March 1-30, 2025 in Tunisia).
ETHICAL CONSIDERATIONS:
The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. The protocol was reviewed by the Institutional Scientific Committee of ISSEPS Sfax and determined to be exempt from formal external ethics committee review under Tunisian regulations governing minimal-risk behavioral research.
This trial was registered retrospectively at ClinicalTrials.gov.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group pilot randomized controlled trial comparing a culturally adapted sleep hygiene education intervention to a control condition (usual habits). Participants were randomized 1:1 using computer-generated block randomization with allocation concealment via sealed envelopes. Outcome assessors conducting cognitive (PVT) and physical performance tests, as well as data analysts, were blinded to group allocation. Participants and the investigator delivering the educational session were unblinded due to the behavioral nature of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Sleep Hygiene Education) | Experimental | Behavioral: Culturally Adapted Sleep Hygiene Education ProgramParticipants receive a single 45-minute culturally adapted sleep hygiene education session prior to Ramadan, followed by written materials, weekly adherence checklists, and bi-weekly SMS reminders throughout Ramadan. |
| Control Group | No intervention | –Participants receive no sleep hygiene education or reminders and are instructed to maintain their usual daily routines and sleep habits throughout the Ramadan period. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male sports science students aged 18 to 30 years
- Intend to fast for the full duration of Ramadan
- No history of diagnosed sleep disorders or medical conditions affecting sleep or cognition
- Free from musculoskeletal injuries that could limit physical performance tests
Key exclusion criteria (4 listed)
- Chronic sleep disorders (e.g., insomnia, obstructive sleep apnea)
- Use of medications known to affect sleep or alertness
- Failure to complete the Ramadan fasting period
- Non-compliance with actigraphy monitoring procedures
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 |
|---|---|---|
| Culturally Adapted Sleep Hygiene Education ProgramA structured educational session addressing sleep scheduling relative to suhoor/iftar, evening light and screen exposure management, caffeine intake regulation, and sleep environment optimization. Delivered as a single 45-minute session before Ramadan, supplemented with written guidelines, weekly self-report checklists, and bi-weekly SMS reminders. | Behavioural | Experimental Group (Sleep Hygiene Education) |
Primary outcome
Total Sleep Time
Time frame: Baseline and Ramadan week 4
Total sleep time in minutes per night, assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline (approximately 2 weeks before Ramadan) through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.
Sleep Efficiency
Time frame: Baseline and Ramadan week 4
Sleep efficiency percentage (ratio of total sleep time to time in bed × 100), assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.
Wake After Sleep Onset (WASO)
Time frame: Baseline and Ramadan week 4
Wake after sleep onset in minutes per night, assessed continuously using wrist actigraphy (ActiGraph wGT3X-BT) from baseline through week 4 of Ramadan. A minimum of 5 valid nights required for analysis at each time point.
6 secondary outcomes
Psychomotor Vigilance - Lapses
Time frame: Baseline and Ramadan week 4
Countermovement Jump Height
Time frame: Baseline and Ramadan week 4
Squat Jump Height
Time frame: Baseline and Ramadan week 4
Handgrip Strength
Time frame: Baseline and Ramadan week 4
Agility Performance
Time frame: Baseline and Ramadan week 4
Psychomotor Vigilance - Mean Reaction Time
Time frame: Baseline and Ramadan week 4
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 Jun 2026.
- Results publication: PubMed 24179309Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available. This includes demographic and anthropometric data, objective sleep outcomes derived from actigraphy (total sleep time, sleep efficiency, wake after sleep onset), psychomotor vigilance test (PVT) results (mean reaction time, lapses), and physical performance test results (countermovement jump, squat jump, handgrip strength, and agility).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Sleep Hygiene Education Program in people with Sleep Disruption and Sleep Hygiene, run by The Higher Institute of Sport and Physical Education of Sfax at 1 site in Tunisia.
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 4 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 12 Jun 2026. 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 Tunisia. 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?
Total Sleep Time (time frame: Baseline and Ramadan week 4). 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?
On the ClinicalTrials.gov record for NCT07639229, which also lists 1 linked publication.
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 Jun 2026.