Auditory HallucinationsNeuro-VRNCT06628323
Neuro-VR: Augmenting a Virtual Reality-based Therapy With Biofeedback for Auditory Hallucinations
A study testing Virtual Reality-based Intervention employing Neurofeedback and Virtual Reality-based Intervention in people with Auditory Hallucinations and Schizophrenia, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The primary goal of this pilot study is to examine the feasibility and acceptability of augmenting a Virtual Reality-based intervention for treating auditory hallucinations in schizophrenia with electroencephalogram (EEG)-based neurofeedback. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Auditory Hallucinations, Schizophrenia
- What is being tested?
- Virtual Reality-based Intervention employing Neurofeedback and Virtual Reality-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent
- Age of 18-65 years
- Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29)
- Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more)
- Identification of at least one dominant voice
- No changes in antipsychotic medications four weeks prior to inclusion in the project
- No planned changes in antipsychotic medication in the 12 weeks following inclusion in the project
- A command of Danish or English sufficient to engage in therapy
Who cannot join
- Rejecting informed consent
- A diagnosis of organic brain disease
- Intellectual disability (IQ ˂ 70)
- A primary diagnosis of substance dependence hindering engaging in therapy
- Hear voices in a language the therapist does not speak
- Inability to tolerate the therapy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Research Center for Mental Health - CORE
Copenhagen, Hellerup, 2900
About this study
Official title: The Neuro-VR Study: A Pilot Study Investigating an Innovative Virtual Reality-based Intervention Employing Biofeedback to Increase Tolerability and Therapy Efficacy in Psychosis
The primary goal of this pilot study is to examine the feasibility and acceptability of augmenting a Virtual Reality-based intervention for treating auditory hallucinations in schizophrenia with electroencephalogram (EEG)-based neurofeedback.
The main questions it aims to answer are:
Read more
- Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations?
- Will VR-NF show indications of being more effective than Virtual Reality-based therapy alone in reducing the severity of auditory hallucinations, improving daily functioning, and enhancing quality of life?
Researchers will compare VR-NF to Virtual Reality-based therapy alone to evaluate therapy effectiveness.
Participants will be allocated to receive 8 sessions of either VR-NF or Virtual Reality-based therapy alone. All participants will undergo a thorough assessment at baseline, and at 12 weeks post-baseline.
Read the detailed description
Auditory hallucinations represent some of the most frequent and debilitating symptoms in schizophrenia spectrum disorders (SSD), affecting up to 80 % of individuals with SSD. Despite receiving treatment with antipsychotic medication, nearly one-third of these individuals continue to experience psychotic symptoms.
Virtual Reality-based interventions have emerged to address the essential need for targeted and effective psychotherapeutic interventions for auditory hallucinations. A recent randomized controlled trial (RCT) has developed and tested a fully immersive Virtual Reality-based intervention, with preliminary results indicating that this approach is effective in mitigating the severity of auditory hallucinations.
The Neuro-VR study aims to improve the effectiveness of this Virtual Reality-based intervention by incorporating real-time EEG-based neurofeedback into the intervention. We expect that augmenting the VR-based intervention with EEG-based neurofeedback will improve both its tolerability and effectiveness by using individual neurophysiological responses to guide the intervention.
The primary objective of the pilot study is to evaluate whether the combination of Virtual Reality and EEG-based neurofeedback is a feasible and acceptable therapeutic approach for treating auditory hallucinations in SSD. A secondary objective is to investigate whether Virtual Reality combined with EEG-based neurofeedback provides indications of being superior to Virtual Reality alone in reducing severity of auditory hallucinations, improving daily functioning and enhancing quality of life in individuals with SSD.
If the pilot study is found successful it could pave the way for broader clinical trials to document the effect of augmenting Virtual Reality-based interventions with real-time feedback from neurophysiological responses. In the long run, this combined approach can be implemented in the mental health clinics to complement traditional treatments.
- Conditions
- Auditory Hallucinations, Schizophrenia
- Being tested
- Virtual Reality-based Intervention employing Neurofeedback, Virtual Reality-based Intervention
- Keywords
- Virtual Reality-based therapy, Schizophrenia, Auditory Hallucinations, Neurofeedback, EEG
- Medical subject headings
- Hallucinations, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based Intervention employing NeurofeedbackBehavioural
Virtual Reality-based intervention augmented with real-time EEG-based neurofeedback targeting auditory hallucinations in schizophrenia
Virtual Reality-based InterventionBehavioural
Virtual Reality-based intervention targeting auditory hallucinations in schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF) | Experimental | Participants in the experimental group undergo 8 sessions of a manualized virtual reality-based intervention added real-time EEG neurofeedback aiming to enhance the control and sense of power in relation to the dominant hallucinated voice. Together with the therapist, the participants create a digital representation (avatar) in virtual reality corresponding to the visual perception and sound of the voice. During therapy, the participants will be encouraged to engage in a dialogue with the avatar. While immersed in virtual reality, EEG recordings will be conducted by electrodes connected to a cap on the participants' head. Processed EEG-data will provide real-time information on the participants' brain activity associated with the emotional distress when confronted with the avatar and will be visible both to the participant and therapist. The feedback will be used to continuously adjust the intervention to the brain activity and aims to help the participant practice emotion regulation. Receives: Behavioral: Virtual Reality-based Intervention employing Neurofeedback |
| Virtual Reality - based therapy | Active comparator | Participants in the control group will be offered 8 sessions of a manualized virtual reality - based therapy that follows the same principles as described in the experimental arm. Together with the therapist, the participants create a digital representation (avatar) in virtual reality that corresponds to their visual perception of and sounds like their hallucinated voice. Thoughout the therapy sessions, the participants will be encouraged to engage in a dialogue with the 'avatar', voiced by the therapist who will alternate between talking as the 'avatar' and as a supportive therapist. The therapy aims at enhancing the participants' control and feeling of power in relation to the dominant hallucinated voice. Furthermore, the therapy focuses on regulating the emotional distress associated with the hallucinated voice. Receives: Behavioral: Virtual Reality-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability as assessed by recruitment rate
Percentage of target sample (30 participants) recruited after 12 months from study start.
Measured: Recruitment rate is monitored throughout the study period (1 year)
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate
Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (8 sessions).
Measured: Retention rates are monitored throughout the study period (1 year)
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group
Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a Likert scale ranging from 1-10 with higher scoring indicating a higher level of satisfaction with therapy.
Measured: At 12 weeks follow up
Secondary outcomes (8)
Severity of positive symptoms (hallucinations, delusions, bizarre behavior and positive formal thought disorder) as assessed by the Scale for the Assessment of Positive Symptoms (SAPS)
SAPS is an interviewer-administered instrument with 34 items measuring positive symptoms in schizophrenia. Each item is rated on a 6-point scale ranging from None (0) to Severe (5) with higher scoring reflecting greater severity of positive symptoms.
Measured: Baseline and at 12 weeks follow up
Severity of auditory hallucinations as assessed by The Psychotic Symptom Rating Scales, Auditory Hallucination subscale (PSYRATS-AH)
PSYRATS-AH is an interviewer-administered instrument with 11 items assessing characteristics of hallucinations: frequency; duration; location; loudness; beliefs about origin of voices; amount of negative content of voices; degree of negative content; amount of distress; intensity of distress; disruption and control.
Each item is rated on a 5-point scale (0-4) with higher scores reflecting greater severity of auditory hallucinations.
Additionally, an optional item measuring Number of Voices will be included.
Measured: Baseline and at 12 weeks follow up
Level of acceptance of and action in relation to the hallucinated voices as assessed by the Voices Acceptance and Action Scale (VAAS)
The VAAS is a self-report scale assessing level of acceptance of and action in relation to the hallucinated voices rated on a 5-point Likert scale ranging from 'Strongly Disagree' (1) to 'Strongly Agree' (5) with higher scores reflecting higher levels of acceptance and action in relation to the hallucinated voices.
Measured: Baseline and at 12 weeks follow up
Beliefs about voice power, voice intent and responding styles as assessed by the revised Beliefs about Voices Questionnaire (BAVQ-R)
The BAVQ-R is a self-report questionnaire assessing beliefs about hallucinated voices. Each item is rated on a 4-point scale ranging from Disagree (0), Unsure (1), Slightly agree (2), Strongly agree (3) with higher scores indicating greater endorsement of a belief.
Measured: Baseline and at 12 weeks follow up
Level of perceived power in relation to the hallucinated voice as assessed by the Voice Power Differential Scale (VPDS)
The VPDS is a self-report questionnaire with seven items rated on a 5-point scale (1-5) with a total score ranging from 7-35. Higher scores indicate that the voice is perceived to have greater power compared to the respondent.
At therapy sessions 1 and 8, the participants will be asked to complete the questionnaire focusing on the hallucinated voice they choose to focus on during therapy.
Measured: Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up
Responding styles to hallucinated voices as assessed by the Assertive Responding to Voices (Approve - Voices) questionnaire
The Assertive Responding to Voices (Approve - Voices) questionnaire comprises 15 items assessing different ways to respond to the hallucinated voices.
Scores range from 0-10 with higher scores indicating higher degree of the specific responding to voices.
At therapy sessions 1 and 8, the participants will be asked to complete the questionnaire focusing on the hallucinated voice they choose to focus on during therapy.
Measured: Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up
Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)
The PSP is an interviewer administered instrument assessing different domains of social and daily functioning: job/education, social relations, personal hygiene and aggressive behaviour.
A total score ranges from 1-100 with higher scores indicating a higher degree of functioning.
Measured: Baseline and at 12 weeks follow up
Social functioning as assessed by the Social Functioning Scale (SFS)
The SFS is a self-report instrument assessing social functioning among individuals with schizophrenia.
The instrument comprises seven domains: Social engagement/withdrawal, Interpersonal behaviour, Prosocial activities, Recreation, Independence-competence, Independence-performance and Employment/occupation.
The minimum raw score is 0 and maximum raw score is 223 with higher scoring indicating a higher level of functioning.
Measured: Baseline and at 12 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start12 Nov 2024
- Primary completion22 Apr 2026
- Study completionMay 2026 (estimated)
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 Auditory HallucinationsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Breivik Soleim, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Louise B. Glenthøj, DMSc, PhD, Principal investigator, Copenhagen Research Center for Mental Health - CORE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628323
- Sponsor's protocol ID
- H-24010871
- Acronym
- Neuro-VR
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Habla AF, Soleim SB, Due AS, Tinglef TH, Eskelund K, Diaz-I-Calvete J, Larsen KM, Kristensen TD, Ebdrup BH, Nordentoft M, Lyngholm D, Miskowiak KW, Ambrosen KS, Birkedal Glenthoj L. Study protocol for a randomized clinical pilot trial investigating feasibility and efficacy of augmenting a virtual reality-assisted intervention targeting auditory verbal hallucinations with biofeedback: The Neuro-VR study. PLoS One. 2026 Feb 26;21(2):e0333716. doi: 10.1371/journal.pone.0333716. eCollection 2026.
PubMed 41746906
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuro-VR Study: A Pilot Study Investigating an Innovative Virtual Reality-based Intervention Employing Biofeedback to Increase Tolerability and Therapy Efficacy in Psychosis
- ClinicalTrials.gov ID
- NCT06628323
- Acronym / sponsor ID
- Neuro-VR / H-24010871
- Conditions
- Auditory Hallucinations, Schizophrenia
- Keywords
- Virtual Reality-based therapy, Schizophrenia, Auditory Hallucinations, Neurofeedback, EEG
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 4 Oct 2024 (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 primary goal of this pilot study is to examine the feasibility and acceptability of augmenting a Virtual Reality-based intervention for treating auditory hallucinations in schizophrenia with electroencephalogram (EEG)-based neurofeedback.
The main questions it aims to answer are:
- Is Virtual Reality -based therapy supplemented with EEG-based neurofeedback (VR-NF) a feasible and acceptable treatment for auditory hallucinations?
- Will VR-NF show indications of being more effective than Virtual Reality-based therapy alone in reducing the severity of auditory hallucinations, improving daily functioning, and enhancing quality of life?
Researchers will compare VR-NF to Virtual Reality-based therapy alone to evaluate therapy effectiveness.
Participants will be allocated to receive 8 sessions of either VR-NF or Virtual Reality-based therapy alone. All participants will undergo a thorough assessment at baseline, and at 12 weeks post-baseline.
Detailed description
Auditory hallucinations represent some of the most frequent and debilitating symptoms in schizophrenia spectrum disorders (SSD), affecting up to 80 % of individuals with SSD. Despite receiving treatment with antipsychotic medication, nearly one-third of these individuals continue to experience psychotic symptoms.
Virtual Reality-based interventions have emerged to address the essential need for targeted and effective psychotherapeutic interventions for auditory hallucinations. A recent randomized controlled trial (RCT) has developed and tested a fully immersive Virtual Reality-based intervention, with preliminary results indicating that this approach is effective in mitigating the severity of auditory hallucinations.
The Neuro-VR study aims to improve the effectiveness of this Virtual Reality-based intervention by incorporating real-time EEG-based neurofeedback into the intervention. We expect that augmenting the VR-based intervention with EEG-based neurofeedback will improve both its tolerability and effectiveness by using individual neurophysiological responses to guide the intervention.
The primary objective of the pilot study is to evaluate whether the combination of Virtual Reality and EEG-based neurofeedback is a feasible and acceptable therapeutic approach for treating auditory hallucinations in SSD. A secondary objective is to investigate whether Virtual Reality combined with EEG-based neurofeedback provides indications of being superior to Virtual Reality alone in reducing severity of auditory hallucinations, improving daily functioning and enhancing quality of life in individuals with SSD.
If the pilot study is found successful it could pave the way for broader clinical trials to document the effect of augmenting Virtual Reality-based interventions with real-time feedback from neurophysiological responses. In the long run, this combined approach can be implemented in the mental health clinics to complement traditional treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF) | Experimental | Behavioral: Virtual Reality-based Intervention employing NeurofeedbackParticipants in the experimental group undergo 8 sessions of a manualized virtual reality-based intervention added real-time EEG neurofeedback aiming to enhance the control and sense of power in relation to the dominant hallucinated voice. Together with the therapist, the participants create a digital representation (avatar) in virtual reality corresponding to the visual perception and sound of the voice. During therapy, the participants will be encouraged to engage in a dialogue with the avatar. While immersed in virtual reality, EEG recordings will be conducted by electrodes connected to a cap on the participants' head. Processed EEG-data will provide real-time information on the participants' brain activity associated with the emotional distress when confronted with the avatar and will be visible both to the participant and therapist. The feedback will be used to continuously adjust the intervention to the brain activity and aims to help the participant practice emotion regulation. |
| Virtual Reality - based therapy | Active comparator | Behavioral: Virtual Reality-based InterventionParticipants in the control group will be offered 8 sessions of a manualized virtual reality - based therapy that follows the same principles as described in the experimental arm. Together with the therapist, the participants create a digital representation (avatar) in virtual reality that corresponds to their visual perception of and sounds like their hallucinated voice. Thoughout the therapy sessions, the participants will be encouraged to engage in a dialogue with the 'avatar', voiced by the therapist who will alternate between talking as the 'avatar' and as a supportive therapist. The therapy aims at enhancing the participants' control and feeling of power in relation to the dominant hallucinated voice. Furthermore, the therapy focuses on regulating the emotional distress associated with the hallucinated voice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to give informed consent
- Age of 18-65 years
- Diagnosis of schizophrenia spectrum disorder (ICD-10 codes: F20, F22-23; F25-29)
- Symtoms of Auditory Verbal Hallucinations within at least the past 3 months (corresponding to SAPS score of 3 or more)
- Identification of at least one dominant voice
Key exclusion criteria (6 listed)
- Rejecting informed consent
- A diagnosis of organic brain disease
- Intellectual disability (IQ ˂ 70)
- A primary diagnosis of substance dependence hindering engaging in therapy
- Hear voices in a language the therapist does not speak
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 |
|---|---|---|
| Virtual Reality-based Intervention employing NeurofeedbackVirtual Reality-based intervention augmented with real-time EEG-based neurofeedback targeting auditory hallucinations in schizophrenia | Behavioural | Virtual Reality based therapy added real-time EEG-based neurofeedback (VR-NF) |
| Virtual Reality-based InterventionVirtual Reality-based intervention targeting auditory hallucinations in schizophrenia | Behavioural | Virtual Reality - based therapy |
Primary outcome
Feasibility and acceptability as assessed by recruitment rate
Time frame: Recruitment rate is monitored throughout the study period (1 year)
Percentage of target sample (30 participants) recruited after 12 months from study start.
Feasibility and acceptability to the VR-NF intervention as assessed by retention rate
Time frame: Retention rates are monitored throughout the study period (1 year)
Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (8 sessions).
Feasibility and acceptability to the VR-NF intervention as assessed by level of satisfaction in the experimental group
Time frame: At 12 weeks follow up
Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a Likert scale ranging from 1-10 with higher scoring indicating a higher level of satisfaction with therapy.
8 secondary outcomes
Severity of positive symptoms (hallucinations, delusions, bizarre behavior and positive formal thought disorder) as assessed by the Scale for the Assessment of Positive Symptoms (SAPS)
Time frame: Baseline and at 12 weeks follow up
Severity of auditory hallucinations as assessed by The Psychotic Symptom Rating Scales, Auditory Hallucination subscale (PSYRATS-AH)
Time frame: Baseline and at 12 weeks follow up
Level of acceptance of and action in relation to the hallucinated voices as assessed by the Voices Acceptance and Action Scale (VAAS)
Time frame: Baseline and at 12 weeks follow up
Beliefs about voice power, voice intent and responding styles as assessed by the revised Beliefs about Voices Questionnaire (BAVQ-R)
Time frame: Baseline and at 12 weeks follow up
Level of perceived power in relation to the hallucinated voice as assessed by the Voice Power Differential Scale (VPDS)
Time frame: Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up
Responding styles to hallucinated voices as assessed by the Assertive Responding to Voices (Approve - Voices) questionnaire
Time frame: Baseline, 1 week post baseline, 8 weeks post baseline and at 12 weeks follow up
Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)
Time frame: Baseline and at 12 weeks follow up
Social functioning as assessed by the Social Functioning Scale (SFS)
Time frame: Baseline and at 12 weeks follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 41746906Habla AF, Soleim SB, Due AS, Tinglef TH, Eskelund K, Diaz-I-Calvete J, Larsen KM, Kristensen TD, Ebdrup BH, Nordentoft M, Lyngholm D, Miskowiak KW, Ambrosen KS, Birkedal Glenthoj L. Study protocol for a randomized clinical pilot trial investigating feasibility and efficacy of augmenting a virtual reality-assisted intervention targeting auditory verbal hallucinations with biofeedback: The Neuro-VR study. PLoS One. 2026 Feb 26;21(2):e0333716. doi: 10.1371/journal.pone.0333716. eCollection 2026.
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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.
Louise B. Glenthøj, DMSc, PhD principal investigator
Copenhagen Research Center for Mental Health - CORE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-based Intervention employing Neurofeedback and Virtual Reality-based Intervention in people with Auditory Hallucinations and Schizophrenia, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 May 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility and acceptability as assessed by recruitment rate (time frame: Recruitment rate is monitored throughout the study period (1 year)). 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 NCT06628323, 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 6 May 2026.