Sleep DisturbanceTAPASNCT04163003
Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
A study testing Targeted Approaches for Promoting Adolescent Sleep (TAPAS) and Sleep Monitoring Only in people with Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.
Trial summary
The overall aim of Dr. Levenson's research proposal is to test the acceptability, feasibility, and preliminary outcomes of a sleep promotion program delivered to 13-15 year olds who report insufficient sleep. Dr. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Targeted Approaches for Promoting Adolescent Sleep (TAPAS) and Sleep Monitoring Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 25 Aug 2022
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ages 13-15;
- sufficient sleep (>7.5 hours of sleep);
- willing/able to provide informed assent/consent.
Who cannot join
- Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder will exclude potential participants;
- unstable medical conditions;
- use of psychotropic medications or medications known to impact sleep;
- adolescent pregnancy;
- clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
- current sleep disorders except for sleep-onset insomnia;
Show all 17Show fewer
- extreme evening preference; and
- Currently living >1 hour outside of the greater Pittsburgh region.
- Sufficient Sleepers:
- Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder;
- unstable medical conditions;
- use of psychotropic medications or medications known to impact sleep;
- adolescent pregnancy;
- clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
- current sleep disorders except for sleep-onset insomnia;
- extreme evening preference; and
- Currently living >1 hour outside of the greater Pittsburgh region.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The overall aim of Dr. Levenson's research proposal is to test the acceptability, feasibility, and preliminary outcomes of a sleep promotion program delivered to 13-15 year olds who report insufficient sleep. Dr. Levenson will examine the feasibility and acceptability of the program through a randomized pilot trial (n=40) that uses a two-period, wait-list control design. Then, Dr. Levenson will test whether the program is associated with changes in sleep, motivation, and four outcome domains: academic functioning, attention, risk behavior, and affect. Such a broadly relevant program has the potential for enormous public health impact by improving sleep and facilitating healthy development across a range of domains among typically-developing adolescents who are highly vulnerable to adverse consequences.
Read the detailed description
General Description:
This study has two sub-studies: one for youth who experience behaviorally insufficient sleep syndrome (BISS) and one for youth who obtain sufficient sleep. This includes a randomized controlled trial for youth who obtain insufficient sleep (BISS), and a universal education (UE) only intervention for youth who obtain sufficient sleep.
All participants will complete a pre-consent screen. Those with sufficient sleep will complete consent/assent and a full screening assessment, and they will watch a sleep education video (UE). If eligible for the sufficient sleeper study, the full screening assessment will serve as a baseline assessment as well. Participants will complete a follow-up assessment about one month later.
Those who pre-screen as insufficient sleepers will complete consent/assent, complete a full screening process, and watch a sleep education video (UE). Those who remain eligible after the full screening process will complete a baseline assessment. Then, youth will be randomized to the TAPAS intervention or to a wait-list control (monitoring only). After completing the post-period 1 follow-up assessment, those in the wait-list control group will switch to the other arm, via a cross-over design. Participants in the intervention-first group will continue to receive the intervention iin Period 2 after post-period 1. After this period, participants will complete the post-period 2 follow-up assessment.
Detailed Description:
Participants. Youth ages 13-15 will be recruited through various methods (e.g., social media advertising, University research registry, flyers, email listservs and online magazines, and from the waiting room of the Children's Hospital of Pittsburgh Center for Adolescent and Young Adult Health (CAYAH)). Among those screened, the investigators will deliver universal education about sleep and conduct baseline and follow-up assessments among n=35 sufficient sleepers. Investigators will randomize n=50 with insufficient sleep to the TAPAS intervention or wait-list control (monitoring only). Overall, investigators plan to collect complete data on n=40 participants, after attrition.
Baseline assessments will include: measures of sleep (sleep diary and actigraphy), academic functioning, attention, affect, motivation, and risk behavior.
TAPAS Intervention. Program goals are to increase knowledge about healthy sleep practices, to increase sleep duration by going to bed earlier (sleep extension), and to increase regularity in sleep timing over the week by limiting oversleeping on the weekends. During the 45-60 minute intervention session, the youth and clinician will discuss the youth's sleep timing and quality and explore the youth's attitudes and social influences on sleep. The clinician will develop discrepancies between current sleep behavior and the youth's values and goals.
It is proposed that the 4-8-week text messaging/web-based portion of the intervention will begin immediately after the clinician session. Participants will receive twice-weekly summaries of their sleep based on diary entries. Participants will then be asked via the web if they'd like to modify their sleep, providing them with autonomy in their answer. Investigators will rely on strategies for extending and regularizing sleep.
Wait-List Control (monitoring only) Condition. The wait-list is proposed to last half the duration as the targeted intervention (4 vs 8 weeks). Participants will monitor sleep with the sleep diary, but they will not receive feedback or any other information on their sleep.
Participants will repeat the baseline assessments and 7 days of actigraphy at the end of Period 1 and at the end of Period 2 (only those randomized to Wait-List Control will cross-over to TAPAS intervention for Period 2).
Follow-up assessments will include: measures of sleep (sleep diary and actigraphy), academic functioning, attention, affect, motivation, and risk behavior.
- Conditions
- Sleep Disturbance
- Being tested
- Targeted Approaches for Promoting Adolescent Sleep (TAPAS), Sleep Monitoring Only
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Approaches for Promoting Adolescent Sleep (TAPAS)Behavioural
Also called TAPAS
The targeted intervention is a three part sleep program, involving a 2- minute psychoeducation video, an in-person session with a clinician focusing on sleep, and web-based goal setting related to sleep behaviors. Intervention approaches to promoting adolescent sleep and reducing insufficient sleep use a motivational interviewing style, rooted in cognitive-behavioral strategies for improving sleep.
Sleep Monitoring OnlyBehavioural
Participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.
| Study group | Role | What they receive |
|---|---|---|
| TAPAS | Experimental | Participants will participate in the TAPAS intervention, which will consist of one in-person engagement session with a therapist and 8 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. Receives: Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS) |
| Sleep monitoring only, then TAPAS | Experimental | Participants will participate in sleep monitoring only first, then participate in the TAPAS intervention. First, participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.TAPAS will consist of one engagement session with a therapist and 4 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. Sleep monitoring is proposed to last the same duration as the targeted intervention in this arm. Receives: Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS); Behavioral: Sleep Monitoring Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition
Participant attrition rate
Measured: 4 weeks
Response Rate
Participant response rate to electronic intervention prompts
Measured: 4 weeks
Adherence
A locally-developed Sleep Promotion Program Rating form indicates which program components covered in each clinician session. The measure is a checklist that indicates the presence or absence of each component covered in the session.
Measured: 1 session
Participant Satisfaction
A locally-developed Treatment Satisfaction Questionnaire measures program satisfaction. Scores range from 18 to 75, with higher scores indicating greater satisfaction.
Measured: 4 weeks
Sleep Diary Sleep Duration
Average sleep duration (in hours and minutes) as measured by sleep diary
Measured: 4 weeks
Sleep Diary Sleep Timing
Average sleep timing as measured by sleep diary
Measured: 4 weeks
Sleep Diary Weekend-Weekday Sleep Timing Differences
Difference in average weekend and weekday sleep timing as measured by sleep diary
Measured: 4 weeks
Secondary outcomes (3)
Actigraphy Sleep Duration
Average sleep duration (in hours and minutes) as measured by actigraphy
Measured: 4 weeks
Actigraphy Sleep Timing
Average sleep timing as measured by actigraphy
Measured: 4 weeks
Actigraphy Weekend-Weekday Sleep Timing Differences
Differences in average weekend and weekday sleep timing as measured by actigraphy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start24 Oct 2019
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Among those with insufficient sleep, after participants are screened and receive universal education about sleep, those with insufficient sleep will be offered to participate in the randomized pilot trial. There are two arms in the randomized trial: TAPAS intervention, and wait-list control (monitoring only). The study will enroll n=50 participants in the Randomized Control Trial (RCT) to obtain full data on n=40 participants after attrition. Participants who obtain sufficient sleep will not be randomized, but will obtain the universal education only. Investigators anticipate enrolling n=35 adolescents with sufficient sleep.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jessica Levenson, University of Pittsburgh
- Investigators
- Jessica C Levenson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163003
- Sponsor's protocol ID
- STUDY19080033
- Other IDs
- K23HD087433
- Acronym
- TAPAS
- Status last verified
- Oct 2022
- First submitted
- 24 Sep 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wescott DL, Goldstein TR, Wallace ML, Miller E, Buysse DJ, Harvey A, Suffoletto B, Rofey DL, Levenson JC. Effects of a single session intervention on actigraphy-measured sleep for adolescents with insufficient and irregular sleep: A randomized controlled trial. Sleep Health. 2026 Apr;12(2):333-339. doi: 10.1016/j.sleh.2025.12.008. Epub 2026 Jan 19.
PubMed 41558877Levenson JC, Goldstein TR, Wallace ML, Witt R, Harvey AG, Buysse D, Rofey DL, Suffoletto B, Miller E. A sleep promotion program for insufficient sleep among adolescents: a pilot feasibility randomized controlled trial. J Clin Sleep Med. 2025 Mar 1;21(3):529-541. doi: 10.5664/jcsm.11456.
PubMed 39506293
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intervention for Insufficient Sleep Among Typically-Developing Adolescents
- ClinicalTrials.gov ID
- NCT04163003
- Acronym / sponsor ID
- TAPAS / STUDY19080033
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 14 Nov 2019 (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 overall aim of Dr. Levenson's research proposal is to test the acceptability, feasibility, and preliminary outcomes of a sleep promotion program delivered to 13-15 year olds who report insufficient sleep. Dr. Levenson will examine the feasibility and acceptability of the program through a randomized pilot trial (n=40) that uses a two-period, wait-list control design. Then, Dr. Levenson will test whether the program is associated with changes in sleep, motivation, and four outcome domains: academic functioning, attention, risk behavior, and affect. Such a broadly relevant program has the potential for enormous public health impact by improving sleep and facilitating healthy development across a range of domains among typically-developing adolescents who are highly vulnerable to adverse consequences.
Detailed description
General Description:
This study has two sub-studies: one for youth who experience behaviorally insufficient sleep syndrome (BISS) and one for youth who obtain sufficient sleep. This includes a randomized controlled trial for youth who obtain insufficient sleep (BISS), and a universal education (UE) only intervention for youth who obtain sufficient sleep.
All participants will complete a pre-consent screen. Those with sufficient sleep will complete consent/assent and a full screening assessment, and they will watch a sleep education video (UE). If eligible for the sufficient sleeper study, the full screening assessment will serve as a baseline assessment as well. Participants will complete a follow-up assessment about one month later.
Those who pre-screen as insufficient sleepers will complete consent/assent, complete a full screening process, and watch a sleep education video (UE). Those who remain eligible after the full screening process will complete a baseline assessment. Then, youth will be randomized to the TAPAS intervention or to a wait-list control (monitoring only). After completing the post-period 1 follow-up assessment, those in the wait-list control group will switch to the other arm, via a cross-over design. Participants in the intervention-first group will continue to receive the intervention iin Period 2 after post-period 1. After this period, participants will complete the post-period 2 follow-up assessment.
Detailed Description:
Participants. Youth ages 13-15 will be recruited through various methods (e.g., social media advertising, University research registry, flyers, email listservs and online magazines, and from the waiting room of the Children's Hospital of Pittsburgh Center for Adolescent and Young Adult Health (CAYAH)). Among those screened, the investigators will deliver universal education about sleep and conduct baseline and follow-up assessments among n=35 sufficient sleepers. Investigators will randomize n=50 with insufficient sleep to the TAPAS intervention or wait-list control (monitoring only). Overall, investigators plan to collect complete data on n=40 participants, after attrition.
Baseline assessments will include: measures of sleep (sleep diary and actigraphy), academic functioning, attention, affect, motivation, and risk behavior.
TAPAS Intervention. Program goals are to increase knowledge about healthy sleep practices, to increase sleep duration by going to bed earlier (sleep extension), and to increase regularity in sleep timing over the week by limiting oversleeping on the weekends. During the 45-60 minute intervention session, the youth and clinician will discuss the youth's sleep timing and quality and explore the youth's attitudes and social influences on sleep. The clinician will develop discrepancies between current sleep behavior and the youth's values and goals.
It is proposed that the 4-8-week text messaging/web-based portion of the intervention will begin immediately after the clinician session. Participants will receive twice-weekly summaries of their sleep based on diary entries. Participants will then be asked via the web if they'd like to modify their sleep, providing them with autonomy in their answer. Investigators will rely on strategies for extending and regularizing sleep.
Wait-List Control (monitoring only) Condition. The wait-list is proposed to last half the duration as the targeted intervention (4 vs 8 weeks). Participants will monitor sleep with the sleep diary, but they will not receive feedback or any other information on their sleep.
Participants will repeat the baseline assessments and 7 days of actigraphy at the end of Period 1 and at the end of Period 2 (only those randomized to Wait-List Control will cross-over to TAPAS intervention for Period 2).
Follow-up assessments will include: measures of sleep (sleep diary and actigraphy), academic functioning, attention, affect, motivation, and risk behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Among those with insufficient sleep, after participants are screened and receive universal education about sleep, those with insufficient sleep will be offered to participate in the randomized pilot trial. There are two arms in the randomized trial: TAPAS intervention, and wait-list control (monitoring only). The study will enroll n=50 participants in the Randomized Control Trial (RCT) to obtain full data on n=40 participants after attrition. Participants who obtain sufficient sleep will not be randomized, but will obtain the universal education only. Investigators anticipate enrolling n=35 adolescents with sufficient sleep.
| Arm | Type | Receives |
|---|---|---|
| TAPAS | Experimental | Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS)Participants will participate in the TAPAS intervention, which will consist of one in-person engagement session with a therapist and 8 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. |
| Sleep monitoring only, then TAPAS | Experimental | Behavioral: Targeted Approaches for Promoting Adolescent Sleep (TAPAS), Behavioral: Sleep Monitoring OnlyParticipants will participate in sleep monitoring only first, then participate in the TAPAS intervention. First, participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.TAPAS will consist of one engagement session with a therapist and 4 weeks of web-based automated intervention prompts. The program will utilize empirically supported approaches for promoting sleep health, delivered in-person and via text-message, focusing on: tailored psychoeducation, motivation and efficacy to change sleep, extending sleep duration, and regularizing sleep timing across the week. Sleep monitoring is proposed to last the same duration as the targeted intervention in this arm. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ages 13-15;
- sufficient sleep (>7.5 hours of sleep);
- willing/able to provide informed assent/consent.
Key exclusion criteria (17 listed)
- Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder will exclude potential participants;
- unstable medical conditions;
- use of psychotropic medications or medications known to impact sleep;
- adolescent pregnancy;
- clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
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 |
|---|---|---|
| Targeted Approaches for Promoting Adolescent Sleep (TAPAS)Also: TAPASThe targeted intervention is a three part sleep program, involving a 2- minute psychoeducation video, an in-person session with a clinician focusing on sleep, and web-based goal setting related to sleep behaviors. Intervention approaches to promoting adolescent sleep and reducing insufficient sleep use a motivational interviewing style, rooted in cognitive-behavioral strategies for improving sleep. | Behavioural | Sleep monitoring only, then TAPAS, TAPAS |
| Sleep Monitoring OnlyParticipants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep. | Behavioural | Sleep monitoring only, then TAPAS |
Primary outcome
Attrition
Time frame: 4 weeks
Participant attrition rate
Response Rate
Time frame: 4 weeks
Participant response rate to electronic intervention prompts
Adherence
Time frame: 1 session
A locally-developed Sleep Promotion Program Rating form indicates which program components covered in each clinician session. The measure is a checklist that indicates the presence or absence of each component covered in the session.
Participant Satisfaction
Time frame: 4 weeks
A locally-developed Treatment Satisfaction Questionnaire measures program satisfaction. Scores range from 18 to 75, with higher scores indicating greater satisfaction.
Sleep Diary Sleep Duration
Time frame: 4 weeks
Average sleep duration (in hours and minutes) as measured by sleep diary
Sleep Diary Sleep Timing
Time frame: 4 weeks
Average sleep timing as measured by sleep diary
Sleep Diary Weekend-Weekday Sleep Timing Differences
Time frame: 4 weeks
Difference in average weekend and weekday sleep timing as measured by sleep diary
3 secondary outcomes
Actigraphy Sleep Duration
Time frame: 4 weeks
Actigraphy Sleep Timing
Time frame: 4 weeks
Actigraphy Weekend-Weekday Sleep Timing Differences
Time frame: 4 weeks
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 Oct 2022.
- Derived from this study: PubMed 41558877Wescott DL, Goldstein TR, Wallace ML, Miller E, Buysse DJ, Harvey A, Suffoletto B, Rofey DL, Levenson JC. Effects of a single session intervention on actigraphy-measured sleep for adolescents with insufficient and irregular sleep: A randomized controlled trial. Sleep Health. 2026 Apr;12(2):333-339. doi: 10.1016/j.sleh.2025.12.008. Epub 2026 Jan 19.
- Derived from this study: PubMed 39506293Levenson JC, Goldstein TR, Wallace ML, Witt R, Harvey AG, Buysse D, Rofey DL, Suffoletto B, Miller E. A sleep promotion program for insufficient sleep among adolescents: a pilot feasibility randomized controlled trial. J Clin Sleep Med. 2025 Mar 1;21(3):529-541. doi: 10.5664/jcsm.11456.
- 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.
Jessica C Levenson, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Approaches for Promoting Adolescent Sleep (TAPAS) and Sleep Monitoring Only in people with Sleep Disturbance, run by University of Pittsburgh 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 3 inclusion and 17 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 Oct 2022. 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?
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?
Attrition (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT04163003, which also lists 2 linked publications.
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 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.