ArthropathyNCT07386561
Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty
A study testing Immersive Virtual Reality Therapy, Non-Sleep Deep Rest Relaxation and Conventional rehabilitation in people with Arthropathy and Osteoarthritis, Hip, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The aim of this study is to compare the effectiveness of Virtual Reality therapy (VR therapy), Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in older adults following hip or knee arthroplasty, focusing on reducing psychological stress and… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Arthropathy, Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- Immersive Virtual Reality Therapy, Non-Sleep Deep Rest Relaxation and Conventional rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 21 Nov 2025to 30 Jun 2026
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 60 years and above who have recently (within the past 3 months) undergone knee or hip joint arthroplasty surgery.
Who cannot join
- Hearing impairment preventing the use of audio recordings;
- Cognitive impairment precluding independent completion of study questionnaires (MMSE <24);
- History of disorders of consciousness, psychotic symptoms, bipolar disorder, or other severe psychiatric disorders;
- Current use of psychoactive medications;
- Ongoing psychiatric treatment or participation in individual psychological therapy;
- Functional status precluding independent ambulation (e.g., wheelchair-bound or bedridden; use of orthopedic aids such as crutches or a walker is permitted);
- Withdrawal of consent or refusal to participate at any stage of the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site
St. Hedwig of Silesia Hospital in Trzebnica
Trzebnica, Lower Silesian Voivodeship, 55-100
About this study
Official title: Adjunctive Virtual Reality Therapy Versus Non-Sleep Deep Rest Relaxation During Postoperative Rehabilitation in Older Adults Undergoing Hip or Knee Arthroplasty
The aim of this study is to compare the effectiveness of Virtual Reality therapy (VR therapy), Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in older adults following hip or knee arthroplasty, focusing on reducing psychological stress and improving functional recovery.
Read the detailed description
Older adults undergoing hip or knee arthroplasty frequently experience psychological distress, including elevated stress and anxiety, which may reduce engagement in rehabilitation and limit functional recovery. This randomized clinical trial will compare the effectiveness of Virtual Reality therapy (VR therapy) and Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in this population. Ninety participants aged 60-85 years, within three months post-arthroplasty, will be recruited from an inpatient rehabilitation unit and randomized to receive standard rehabilitation alone, standard rehabilitation plus VR therapy or standard rehabilitation plus NSDR relaxation over a four-week period. The VR therapy will consist of eight 20-minute session using VRTierOne medical device. NSDR relaxation will be delivered as eight 20-minute, audio-guided relaxation sessions (body scan and breathing exercises) via noise-cancelling headphones in a quiet environment. The primary outcome was psychological distress, assessed using the HADS total score at baseline and after the 4-week intervention. Both adjuncts are designed to be safe, well-tolerated, and feasible for clinical implementation. The findings are expected to clarify the comparative role of VR therapy and NSDR relaxation as low-risk adjunctive strategies to support psychological well-being and functional outcomes during post-arthroplasty rehabilitation.
- Conditions
- Arthropathy, Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- Immersive Virtual Reality Therapy, Non-Sleep Deep Rest Relaxation, Conventional rehabilitation
- Keywords
- virtual reality, arthroplasty, psychological outcomes, functional state, anxiety, stress, ortopedic rehabilitation, relaxation
- Medical subject headings
- Joint Diseases, Osteoarthritis, Hip, Osteoarthritis, Knee, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality TherapyDevice
8 sessions of VR therapy over 4 weeks (each of them 20 minutes long). As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.
Non-Sleep Deep Rest RelaxationBehavioural
The experimental group will receive eight sessions of audio recording based on the Non-Sleep Deep Rest (NSDR) concept during the 4-week rehabilitation program. Each 20-minute session is conducted in a quiet setting using noisecancelling headphones. The recording guides patients through a structured body scan, directing attention sequentially to specific body regions and prompting active muscle relaxation. Body scanning is combined with mindful breathing to deepen relaxation and attenuate sympathetic nervous system activity. Therapeutic suggestions focus on reframing overload versus relief, letting go versus holding on, and balancing action with awareness. The intervention aims to enhance psychological resilience and support the balance between the sympathetic and parasympathetic parts of the autonomic nervous system. The protocol is non-invasive, safe, and feasible for routine clinical use.
Conventional rehabilitationBehavioural
Conventional rehabilitation follows standard postoperative protocols after hip or knee arthroplasty. The 4-week program includes five weekly sessions. Gait training is conducted in hospital corridors under physiotherapist supervision, using assistive devices as needed (crutches, walkers). Daily therapy includes 120 minutes of kinesiotherapy (general exercises and gait training), 30 minutes of ergotherapy to improve functional independence, and three individualized physical therapy procedures (laser therapy, magnetic therapy, or electrotherapy) tailored to patient needs.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Therapy Group | Experimental | Conventional orthopedic rehabilitation supplemented by VR therapy Receives: Device: Immersive Virtual Reality Therapy; Behavioral: Conventional rehabilitation |
| NSDR Group | Experimental | Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation Receives: Behavioral: Non-Sleep Deep Rest Relaxation; Behavioral: Conventional rehabilitation |
| Conventional Rehabilitation Group | Active comparator | Conventional orthopedic rehabilitation Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS) Total Score at 4 Weeks
The Hospital Anxiety and Depression Scale (HADS) is a 14-item instrument assessing anxiety and depression symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 42. Higher scores indicate greater symptom severity.
Measured: Baseline and 4 weeks
Secondary outcomes (13)
Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) Score at 4 Weeks
The Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) is a 7-item instrument assessing anxiety symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity.
Measured: Baseline and 4 weeks
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
The Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) is a 7-item instrument assessing depressive symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater depressive symptom severity.
Measured: Baseline and 4 weeks
Modified Rivermead Motor Assessment - Gross Function (RMA-GF) Score at 4 Weeks
The Gross Function section of the Rivermead Motor Assessment (RMA-GF) evaluates gross motor mobility, including transfers, standing, walking, and stair negotiation. A modified 11-item version was used. The 10-meter running and jumping items from the original 13-item scale were excluded because these activities were not considered appropriate during early rehabilitation following total hip or knee arthroplasty. Each task was scored as completed (1 point) or not completed (0 points), resulting in a total score ranging from 0 to 11. Higher scores indicate better functional mobility.
Measured: Baseline and 4 weeks
Short Physical Performance Battery (SPPB) Score at 4 Weeks
The Short Physical Performance Battery (SPPB) combines assessments of balance, gait speed, and chair stand tests, with composite scores ranging from 0 (worst) to 12 (best). Higher scores indicate better physical function.
Measured: Baseline and 4 weeks
Barthel Index Score at 4 Weeks
The Barthel Index assesses independence in activities of daily living (ADL), with scores ranging from 0 to 100. Higher scores represent greater functional independence.
Measured: Baseline and 4 weeks
Tinetti's Short Scale Score at 4 Weeks
Tinetti's Short Scale assesses fall risk through evaluation of gait and balance over five tasks. Scores range from 0 to 15, with higher scores indicating better functional mobility.
Measured: Baseline and 4 weeks
Visual Analogue Scale (VAS) Score at 4 Weeks
The Visual Analogue Scale (VAS) was used to assess current pain intensity. Participants indicated their pain on a 100-mm horizontal line anchored by "no pain" at 0 mm and "worst pain imaginable" at 100 mm. The recorded values were transformed to a 0-10 scale for analysis, with higher scores indicating greater pain intensity.
Measured: Baseline and 4 weeks
Perceived Stress Scale (PSS-10) Score at 4 Weeks
The Perceived Stress Scale (PSS-10) is a 10-item scale measuring perceived stress over the past month. Scores range from 0 to 40, with higher scores reflecting greater perceived stress.
Measured: Baseline and 4 weeks
Generalized Self-Efficacy Scale (GSES) Score at 4 Weeks
The Generalized Self-Efficacy Scale (GSES) is a 10-item measure of general self-efficacy, meaning a person's broad belief in their ability to cope with difficult demands and handle challenges. Items are rated on a 4-point scale and summed to a total score ranging from 10 to 40. Higher scores reflect greater generalized self-efficacy.
Measured: Baseline and 4 weeks
Perception of Stress Questionnaire (PSQ) Score at 4 Weeks
The Perception of Stress Questionnaire (PSQ) is a 27-item measure of perceived stress, with scores ranging from 21 to 105. Higher scores reflect greater stress perception.
Measured: Baseline and 4 weeks
Perception of Stress Questionnaire Emotional Tension Subscale Score at 4 Weeks
The Emotional Tension subscale of the Perception of Stress Questionnaire (PSQ) consists of 7 items. Scores range from 7 to 35, with higher scores indicating greater emotional tension.
Measured: Baseline and 4 weeks
Perception of Stress Questionnaire External Stress Subscale Score at 4 Weeks
The External Stress subscale of the Perception of Stress Questionnaire (PSQ) consists of 7 items. Scores range from 7 to 35, with higher scores indicating greater stress associated with external demands and circumstances.
Measured: Baseline and 4 weeks
Perception of Stress Questionnaire Intrapsychic Stress Subscale Score at 4 Weeks
The Intrapsychic Stress subscale of the Perception of Stress Questionnaire (PSQ) consists of 7 items. Scores range from 7 to 35, with higher scores indicating greater intrapsychic stress.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start21 Nov 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, Jan Dlugosz University in Czestochowa
- Responsible party
- Principal investigator, Joanna Szczepańska-Gieracha, Wroclaw University of Health and Sport Sciences
- Investigators
- Joanna Szczepańska-Gierahca, PhD, Principal investigator, Wrocław University of Health and Sport SciencesJustyna Mazurek, PhD, Principal investigator, Wroclaw Medical UniversityBłażej Cieślik, PhD, Principal investigator, Jan Dlugosz University in Czestochowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386561
- Sponsor's protocol ID
- KE-U/108/2025
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Aug 2026
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Virtual Reality Therapy Versus Non-Sleep Deep Rest Relaxation During Postoperative Rehabilitation in Older Adults Undergoing Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07386561
- Acronym / sponsor ID
- KE-U/108/2025
- Conditions
- Arthropathy, Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- virtual reality, arthroplasty, psychological outcomes, functional state, anxiety, stress, ortopedic rehabilitation, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, Jan Dlugosz University in Czestochowa
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 4 Feb 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.
The aim of this study is to compare the effectiveness of Virtual Reality therapy (VR therapy), Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in older adults following hip or knee arthroplasty, focusing on reducing psychological stress and improving functional recovery.
Detailed description
Older adults undergoing hip or knee arthroplasty frequently experience psychological distress, including elevated stress and anxiety, which may reduce engagement in rehabilitation and limit functional recovery. This randomized clinical trial will compare the effectiveness of Virtual Reality therapy (VR therapy) and Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in this population. Ninety participants aged 60-85 years, within three months post-arthroplasty, will be recruited from an inpatient rehabilitation unit and randomized to receive standard rehabilitation alone, standard rehabilitation plus VR therapy or standard rehabilitation plus NSDR relaxation over a four-week period. The VR therapy will consist of eight 20-minute session using VRTierOne medical device. NSDR relaxation will be delivered as eight 20-minute, audio-guided relaxation sessions (body scan and breathing exercises) via noise-cancelling headphones in a quiet environment. The primary outcome was psychological distress, assessed using the HADS total score at baseline and after the 4-week intervention. Both adjuncts are designed to be safe, well-tolerated, and feasible for clinical implementation. The findings are expected to clarify the comparative role of VR therapy and NSDR relaxation as low-risk adjunctive strategies to support psychological well-being and functional outcomes during post-arthroplasty rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Therapy Group | Experimental | Device: Immersive Virtual Reality Therapy, Behavioral: Conventional rehabilitationConventional orthopedic rehabilitation supplemented by VR therapy |
| NSDR Group | Experimental | Behavioral: Non-Sleep Deep Rest Relaxation, Behavioral: Conventional rehabilitationConventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation |
| Conventional Rehabilitation Group | Active comparator | Behavioral: Conventional rehabilitationConventional orthopedic rehabilitation |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged 60 years and above who have recently (within the past 3 months) undergone knee or hip joint arthroplasty surgery.
Key exclusion criteria (7 listed)
- Hearing impairment preventing the use of audio recordings;
- Cognitive impairment precluding independent completion of study questionnaires (MMSE <24);
- History of disorders of consciousness, psychotic symptoms, bipolar disorder, or other severe psychiatric disorders;
- Current use of psychoactive medications;
- Ongoing psychiatric treatment or participation in individual psychological therapy;
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 |
|---|---|---|
| Immersive Virtual Reality Therapy8 sessions of VR therapy over 4 weeks (each of them 20 minutes long). As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation. | Device | Immersive Virtual Reality Therapy Group |
| Non-Sleep Deep Rest RelaxationThe experimental group will receive eight sessions of audio recording based on the Non-Sleep Deep Rest (NSDR) concept during the 4-week rehabilitation program. Each 20-minute session is conducted in a quiet setting using noisecancelling headphones. The recording guides patients through a structured body scan, directing attention sequentially to specific body regions and prompting active muscle relaxation. Body scanning is combined with mindful breathing to deepen relaxation and attenuate sympathetic nervous system activity. Therapeutic suggestions focus on reframing overload versus relief, letting go versus holding on, and balancing action with awareness. The intervention aims to enhance psychological resilience and support the balance between the sympathetic and parasympathetic parts of the autonomic nervous system. The protocol is non-invasive, safe, and feasible for routine clinical use. | Behavioural | NSDR Group |
| Conventional rehabilitationConventional rehabilitation follows standard postoperative protocols after hip or knee arthroplasty. The 4-week program includes five weekly sessions. Gait training is conducted in hospital corridors under physiotherapist supervision, using assistive devices as needed (crutches, walkers). Daily therapy includes 120 minutes of kinesiotherapy (general exercises and gait training), 30 minutes of ergotherapy to improve functional independence, and three individualized physical therapy procedures (laser therapy, magnetic therapy, or electrotherapy) tailored to patient needs. | Behavioural | Conventional Rehabilitation Group, Immersive Virtual Reality Therapy Group, NSDR Group |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) Total Score at 4 Weeks
Time frame: Baseline and 4 weeks
The Hospital Anxiety and Depression Scale (HADS) is a 14-item instrument assessing anxiety and depression symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 42. Higher scores indicate greater symptom severity.
13 secondary outcomes
Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time frame: Baseline and 4 weeks
Modified Rivermead Motor Assessment - Gross Function (RMA-GF) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Short Physical Performance Battery (SPPB) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Barthel Index Score at 4 Weeks
Time frame: Baseline and 4 weeks
Tinetti's Short Scale Score at 4 Weeks
Time frame: Baseline and 4 weeks
Visual Analogue Scale (VAS) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Perceived Stress Scale (PSS-10) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Generalized Self-Efficacy Scale (GSES) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Perception of Stress Questionnaire (PSQ) Score at 4 Weeks
Time frame: Baseline and 4 weeks
Perception of Stress Questionnaire Emotional Tension Subscale Score at 4 Weeks
Time frame: Baseline and 4 weeks
Perception of Stress Questionnaire External Stress Subscale Score at 4 Weeks
Time frame: Baseline and 4 weeks
Perception of Stress Questionnaire Intrapsychic Stress Subscale Score at 4 Weeks
Time frame: Baseline and 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 3 Aug 2026.
- 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.
Joanna Szczepańska-Gierahca, PhD principal investigator
Wrocław University of Health and Sport Sciences
Justyna Mazurek, PhD principal investigator
Wroclaw Medical University
Błażej Cieślik, PhD principal investigator
Jan Dlugosz University in Czestochowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Therapy, Non-Sleep Deep Rest Relaxation and Conventional rehabilitation in people with Arthropathy and Osteoarthritis, Hip, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 7 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 3 Aug 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 Poland. 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?
Hospital Anxiety and Depression Scale (HADS) Total Score at 4 Weeks (time frame: Baseline and 4 weeks). 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 3 Aug 2026.