Sedative During EndoscopyNCT06349564
Implementing Virtual Reality (VR) to Reduce Sedation
A study testing Pico 4 Enterprise headset with noise cancelling headphones in people with Sedative During Endoscopy, run by NYU Langone Health at 1 site in United States.
Trial summary
The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedative During Endoscopy
- What is being tested?
- Pico 4 Enterprise headset with noise cancelling headphones
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to Sep 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
- Aged 21 to 65
- Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
- Aged 21 to 65
Who cannot join
- Visual impairments such as blindness which would impair them from watching the entertainment videos.
- Patients with history of CAD,
- History of seizures,
- History of vertigo,
- History of allergy to plastic,
- ASAII or III,
Show all 15Show fewer
- Patient with active GI bleed, having either melena or hematochezia.
- CONTROL GROUP
- Visual impairments such as blindness which would impair them from watching the entertainment videos
- Patients with history of CAD
- History of seizures
- History of vertigo
- History of allergy to plastic
- ASAII or III
- Patient with active GI bleed, having either melena or hematochezia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Brooklyn
Brooklyn, New York, 11220
About this study
Official title: Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.
- Conditions
- Sedative During Endoscopy
- Being tested
- Pico 4 Enterprise headset with noise cancelling headphones
- Keywords
- GERD, Dyspepsia, screening colonoscopy, diagnostic upper endoscopy, Gastroesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pico 4 Enterprise headset with noise cancelling headphonesDevice
The device includes a computer tablet and virtual reality headset.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Procedure with VR Headset | Experimental | VR google with noise cancellation headphones will be placed on patients' heads after a time-out. Patients can select from a range of entertainment videos prior and during the procedure. The anesthesiologist will administer minimal sedation. The patient can request additional sedation if needed. VR immersion continues until the procedure concludes and patients are moved to the recovery area. Goggles are removed in the recovery area Receives: Device: Pico 4 Enterprise headset with noise cancelling headphones |
| Endoscopic Procedure only | No intervention | The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of sedative drugs administered during the procedure
Measured: End of procedure, up to 1 hour
Secondary outcomes (7)
Patient-reported discomfort or pain (using 0-10 pain scale)
Measured: During PACU stay, approximately 30 minutes
Duration of the procedure
Measured: End of procedure, up to 1 hour
Overall patient satisfaction scores
Using Likert scale of 1-7. Subjects will be asked to rank several variables on the Likert scale, including overall experience (from 1-very dissatisfied to 7-very satisfied), enjoyability (from 1- not enjoyable to 7-very enjoyable), and anxiety (from 1-extreme anxiety to 7-no anxiety). Scores range from 3-21, higher scores indicate satisfaction.
Measured: During PACU stay, approximately 30 minutes
Number of events of complications from VR
Events such as nausea, vomiting, dizziness.
Measured: During PACU stay, approximately 30 minutes
Number of technical failures
Measured: End of procedure, up to 1 hour
Troubleshooting time
Measured: End of procedure, up to 1 hour
PACU length of stay
Measured: End of PACU stay, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start9 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative During EndoscopyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maysaa El Zoghbi, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349564
- Sponsor's protocol ID
- 23-01443
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Maysaa.ElZoghbi@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
- ClinicalTrials.gov ID
- NCT06349564
- Acronym / sponsor ID
- 23-01443
- Conditions
- Sedative During Endoscopy
- Keywords
- GERD, Dyspepsia, screening colonoscopy, diagnostic upper endoscopy, Gastroesophageal reflux disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Apr 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 study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Procedure with VR Headset | Experimental | Device: Pico 4 Enterprise headset with noise cancelling headphonesVR google with noise cancellation headphones will be placed on patients' heads after a time-out. Patients can select from a range of entertainment videos prior and during the procedure. The anesthesiologist will administer minimal sedation. The patient can request additional sedation if needed. VR immersion continues until the procedure concludes and patients are moved to the recovery area. Goggles are removed in the recovery area |
| Endoscopic Procedure only | No intervention | –The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
- Aged 21 to 65
- Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
- Aged 21 to 65
Key exclusion criteria (15 listed)
- Visual impairments such as blindness which would impair them from watching the entertainment videos.
- Patients with history of CAD,
- History of seizures,
- History of vertigo,
- History of allergy to plastic,
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 |
|---|---|---|
| Pico 4 Enterprise headset with noise cancelling headphonesThe device includes a computer tablet and virtual reality headset. | Device | Endoscopic Procedure with VR Headset |
Primary outcome
Total amount of sedative drugs administered during the procedure
Time frame: End of procedure, up to 1 hour
7 secondary outcomes
Patient-reported discomfort or pain (using 0-10 pain scale)
Time frame: During PACU stay, approximately 30 minutes
Duration of the procedure
Time frame: End of procedure, up to 1 hour
Overall patient satisfaction scores
Time frame: During PACU stay, approximately 30 minutes
Number of events of complications from VR
Time frame: During PACU stay, approximately 30 minutes
Number of technical failures
Time frame: End of procedure, up to 1 hour
Troubleshooting time
Time frame: End of procedure, up to 1 hour
PACU length of stay
Time frame: End of PACU stay, approximately 30 minutes
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 19 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Maysaa.ElZoghbi@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Maysaa El Zoghbi, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pico 4 Enterprise headset with noise cancelling headphones in people with Sedative During Endoscopy, run by NYU Langone Health 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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 19 Mar 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 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?
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?
Contact Maysaa El Zoghbi, MD (216-835-7626, Maysaa.ElZoghbi@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of sedative drugs administered during the procedure (time frame: End of procedure, up to 1 hour). 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 19 Mar 2026.