RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
NCT06553235, Not applicable, Recruiting, Aarhus University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention | ClinicalTrials.gov |
| NCT number | NCT06553235 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 84 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Aarhus University Hospital | ClinicalTrials.gov |
| Conditions | Insomnia, Cognitive Impairment, Breast Cancer | ClinicalTrials.gov |
| Interventions | Cognitive Behavioral Therapy for Insomnia (CBT-I), Sleep hygiene education | ClinicalTrials.gov |
| First posted | 2024-08-14 | ClinicalTrials.gov |
| Last updated | 2025-01-08 | ClinicalTrials.gov |
Registered outcomes 37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Conners continuous performance test 3rd edition | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Conners continuous performance test is a computerized test. It measures a combination of vigilance, sustained attention, and the inhibition component of executive function. | ClinicalTrials.gov |
| Primary | Insomnia Severity Index (ISI) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | The ISI measures the severity of insomnia symptoms and the associated impact on daytime functioning and distress. The questionnaire consists of 7 questions the sum of which makes up a total score. The ISI has a range of 0-28, with higher scores indicate worse insomnia severity. | ClinicalTrials.gov |
| Secondary | Psychomotor Vigilance Test (PVT) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in vigilance will be measured with the Psychomotor Vigilance Test (PVT). | ClinicalTrials.gov |
| Secondary | Trail-Making Test Part A (TMT-A) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in processing speed will be measured using the Trail Making Test A with the outcome measured as time in seconds. | ClinicalTrials.gov |
| Secondary | Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Coding | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in processing speed will be measured with the WAIS-IV Digit Symbol Coding subtest. Scores range from 0 to 135, with higher scores indicating better outcomes. | ClinicalTrials.gov |
| Secondary | Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Digit span | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in attention will be measured using the Digit Span Forwards subtest of the WAIS-IV. Scores range from a minimum of 0 points to a maximum of 16 points, with higher scores indicating better outcomes. Changes in working memory will be measured using the WAIS-IV Digit Span Backwards and Ranking. Both have scores range from a minimum of 0 points to a maximum of 16 points, with higher scores indicating better out-comes. | ClinicalTrials.gov |
| Secondary | Paced Auditory Serial Addition Test (PASAT) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in attention will be measured with the Paced Auditory Serial Addition Test, with scores from 0-60 with higher scores indicating better attention. | ClinicalTrials.gov |
| Secondary | Hopkins Verbal Learning Test-Revised (HVLT-R) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | The Hopkins Verbal Learning Test-Revised (HVLT-R) assesses verbal learning and memory through immediate recall, delayed recall, and delayed recognition tasks. Part 1 has a scoring range from 0 to 36, where higher scores represent better outcomes. Part 2 has a scoring range from 0 to 12, with higher scores also indicating better outcomes. | ClinicalTrials.gov |
| Secondary | Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in learning and visual memory will be assessed using the Brief Visuospatial Memory Test - Revised (BVMT-R). | ClinicalTrials.gov |
| Secondary | Controlled Oral Word Association Test (COWAT) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in verbal fluency will be evaluated using the Controlled Oral Word Association Test (COWAT), assessing both letter and animal categories. Participants will be instructed to generate as many words as possible within a specified time limit for each category. A higher number of words produced indicates a better outcome in verbal fluency for both letter and animal categories. | ClinicalTrials.gov |
| Secondary | Trail-Making Test Part B (TMT-B) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | Changes in executive function will be measured using the Trail Making Test B with the outcome measured as time in seconds. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | The Stroop Color and Word Test will be used to measure cognitive processing speed, selective attention, and executive function. | ClinicalTrials.gov |
| Secondary | Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Information | Baseline (week 0) | Pre-morbid intelligence will be measured using the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Information subtest. Higher scores indicate better performance. | ClinicalTrials.gov |
| Secondary | Glymphatic function | Baseline (week 0), 6-months follow-up (approximately week 33) | Glymphatic function will be assessed using diffusion tensor image analysis along the perivascular space (DTI-ALPS). This involves the calculation of an ALPS-index with higher indices indicating better glymphatic function. | ClinicalTrials.gov |
| Secondary | Structural brain networks | Baseline (week 0), 6-months follow-up (approximately week 33) | Changes in structural brain network organization based on MRI. | ClinicalTrials.gov |
| Secondary | Brain gray matter | Baseline (week 0), 6-months follow-up (approximately week 33) | Changes in brain gray matter as measured with T1-weighted MRI. | ClinicalTrials.gov |
| Secondary | Brain white matter | Baseline (week 0), 6-months follow-up (approximately week 33) | Changes in white matter as measured with T1-weighted MRI. | ClinicalTrials.gov |
| Secondary | Brain white matter microstructure | Baseline (week 0), 6-months follow-up (approximately week 33) | Changes in brain white matter as measured with diffusion-weighted MRI. | ClinicalTrials.gov |
| Secondary | Tumor necrosis factor alpha (TNF-α) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | The concentration of tumor necrosis factor alpha (TNF-α) will be extracted from blood samples. | ClinicalTrials.gov |
| Secondary | Interleukin 1 beta (Il-1β) | Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33) | The concentration of interleukin 1 beta (Il-1β) will be extracted from blood samples. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 10
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)