Trial · NCT05707442
Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
NCT05707442, Phase 3, Recruiting, Beijing Tiantan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE). Trials, record NCT05707442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05707442
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
- NCT number
- NCT05707442
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 74 participants, estimated
- Lead sponsor
- Beijing Tiantan Hospital
- Conditions
- Idiopathic Intracranial Hypotension, Venous Sinus Stenosis
- Interventions
- Stent Implantation, Acetazolamide-based medical therapy, Weight loss
- First posted
- 2023-02-01
- Last updated
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Perimetric Mean Deviation (PMD) | 6 months | The change in perimetric mean deviation (PMD) from baseline to 6 month in the eye with the most severe visual loss at baseline. |
| Secondary | Cerebrospinal Fluid (CSF) Opening Pressure | 6 months | The change in intracranial pressure measured by lumbar puncture opening pressure from baseline to 6 months. |
| Secondary | Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome) | 6 months | The change in papilledema measured by Frisén grade from baseline to 6 months |
| Secondary | Retinal Nerve Fiber Layer Thickness | 6 months | The change in thickness of retinal nerve fiber layer measured by optical coherence tomography (OCT) from baseline to 6 months. |
| Secondary | Total Retinal Thickness | 6 months | The change in thickness of total retina measured by optical coherence tomography (OCT) from baseline to 6 months. |
| Secondary | Visual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function) | 6 months | The change in vision measured by National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) from baseline to 6 months. |
| Secondary | Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function) | 6 months | The change in vision measured by 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)from baseline to 6 months. |
| Secondary | Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity) | 6 months | The change in headache measured by Headache Impact Test-6 (HIT-6) questionnaire from baseline to 6 months. |
| Secondary | Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability) | 6 months | The change in pulsatile tinnitus from baseline to 6 months；pulsatile tinnitus was assessed using the Tinnitus Handicap Inventory (THI), which is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living. |
| Other | Functional health status and quality of life:EuroQol five dimensions questionnaire (EQ-5D,0-100,higher scores mean a better outcome) | 6 months | The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) from baseline to 6 months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05707442
GET https://conductscience.org/api/trials/v1/NCT05707442/registered