Characterizing Sleep Among Long-term Survivors of Childhood Cancer
NCT05480904, Active not recruiting, St. Jude Children's Research Hospital
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Characterizing Sleep Among Long-term Survivors of Childhood Cancer | ClinicalTrials.gov |
| NCT number | NCT05480904 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Enrollment | 199 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | St. Jude Children's Research Hospital | ClinicalTrials.gov |
| Conditions | ALL, Adult, CNS Tumor, Solid Tumor | ClinicalTrials.gov |
| Interventions | Neurocognitive (Thinking) Testing, CNS Vital Signs (Thinking) Testing, Health Questionnaires, Sleep Surveys & Sleep Diary, Echocardiography/EKG, Pulmonary Function, Remote Polysomnography, Physical Function | ClinicalTrials.gov |
| First posted | 2022-07-29 | ClinicalTrials.gov |
| Last updated | 2026-08-19 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Insomnia Severity Index (ISI) | Baseline | ISI is a seven-item questionnaire that looks at symptoms of clinical insomnia. The ISI assesses insomnia symptoms over the past 14 days and has demonstrated good reliability and validity. The total ISI score ranges from 0 to 28, with scores \< 8 indicating no significant insomnia. | ClinicalTrials.gov |
| Primary | CSALTS Sleep Survey | Baseline | CSALTS Sleep Survey incorporating Epworth Sleepiness Scale (EPS) and Pittsburg Sleep Quality Index (PSQI) The CSALTS Sleep Survey assesses sleep quality, patterns, and daytime sleepiness. It incorporates 19 questions from the PSQI and 8 questions of the ESS. The PSQI and ESS total scores will be reported. | ClinicalTrials.gov |
| Primary | Morningness-Eveningness Questionnaire (MEQ) | Baseline | The MEQ is a 19-question measure that assesses the degree to which respondents are active and alert at certain times of the day. Each item is rated using a Likert-type scale with lower scales reflecting a more evening-type characterization of alertness. Global scores range from 16 to 86 and these values are used to define 'definitely morning type' (70-86), 'moderately morning type' (59-69), 'neither type' (42-58), 'moderately evening type' (31-41), and 'definitely evening type' (16-30). | ClinicalTrials.gov |
| Primary | Circadian Type Inventory (CTI) | Baseline | CTI is an 11-item questionnaire that looks at rigidity/flexibility of sleeping habits and ability/inability to overcome drowsiness (i.e., circadian rhythm disorders). Respondents use a 5-item, Likert-type scale to answer questions regarding their sleep habits and preferences. Scales range from 1 ("almost never") to 5 ("almost always"). Higher scores on the rigidity subscales indicate a greater flexibility in circadian rhythm, while lower scores on the overcoming-drowsiness subscale indicate a greater ability to manage on less sleep. | ClinicalTrials.gov |
| Primary | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT) | Baseline | fatigue scale is a short 13-item tool that provides a single measure of an individual's level of fatigue during a usual day. | ClinicalTrials.gov |
| Primary | CSALTS Pain Survey | Baseline for 2 nights | The 7-item pain survey will include pain interference questions from the SJLIFE Behavioral Survey and one pain intensity question. The six items that measures amount of pain interference in daily activities in last 7 days is measured from "not at all" to "very much." The pain intensity question is measured 1-10 with 10 "worst imaginable pain." | ClinicalTrials.gov |
| Primary | Polysomnography Evaluation (Sleep Profiler PSG2 or WatchPAT) | Baseline | The Sleep Profiler PSG2 measures brain waves during sleep, blood oxygen levels, heart rate, and breathing and will measure different patterns of sleep stages. Two nights of data collection will be requested though one night will be sufficient if the participant sleeps at least 4 hours. The apnea hypopnea index and sleep efficiency scores will be reported. The WatchPAT device assesses sleep timing, sleep staging, and sleep apnea events via a device worn on the wrist that measures limb movement, peripheral arterial tone and connects to an EKG electrode. Two nights of data collection will be requested though one night will be sufficient if the participant sleeps at least 4 hours. The apnea hypopnea index and sleep efficiency scores will be reported | ClinicalTrials.gov |
| Secondary | Sustained Attention -Conners Continuous Performance Test 3rd Ed or CNS-VS CPT. | Baseline | Computerized test of omissions, variability, and reaction time, requiring participants to respond to letter stimuli on the screen quickly and accurately, while avoiding targets. These three scores will be reported in T scores. | ClinicalTrials.gov |
| Secondary | Memory-California Verbal Learning Test 2nd Ed. | Baseline | Orally administered test of verbal learning, short-term and long-term verbal free-recall memory, requiring participant to learn and remember a list of words, measured in T-score and z-scores. | ClinicalTrials.gov |
| Secondary | Executive Functions -Trail Making Test or CNS-VS Shifting Attention Test | Baseline | The Trail Making Test is a timed task that requires a participant to shift his/her attention adaptively and flexibly. Considered a measure of cognitive flexibility. Standard score for Trail Making Letter-Word Switching will be reported. Shifting Attention Test (SAT) measure cognitive flexibility with a single standard score. | ClinicalTrials.gov |
| Secondary | Executive Functions- Verbal Fluency Test Controlled Oral Word Association (COWA) or CNS-VS Stroop Test | Baseline | This is a task of cognitive/verbal fluency. Participants are given a letter and must say as many words that start with that letter within 60 seconds. A single age-adjusted z-score will be reported. Stroop Test (ST) measures cognitive control and fluency with a single standard score | ClinicalTrials.gov |
| Secondary | Executive Functions -Digit Span Backward | Baseline | Digit Span Backward: Digit Span Backward (DSB), from the Digit Span subtest on the WAIS-IV, is a measure of working memory. The number of digits recalled in the longest span is converted to a standard score using age-based norms. Considered a process score on the WAIS-IV DSB is found to have acceptable reliability and validity parameters. | ClinicalTrials.gov |
| Other | Intelligence | Baseline | WASI-II assessment of intelligence that provides composite scores that estimate verbal comprehension and perceptual reasoning abilities, requiring participants to define words and complete visual puzzles, measured in T scores converted to Standard Scores for Full Scale IQ. | ClinicalTrials.gov |
| Other | Processing Speed - Coding/Digit Symbol or CNS-VS Symbol Digit Test | Baseline | Written timed test of processing speed, requiring participant to copy abstract symbols matched with numbers, measured in a single scaled score | ClinicalTrials.gov |
| Other | Processing Speed-Grooved Pegboard | Baseline | Timed test of fine motor dexterity and speed, requiring participant to put small metal pegs into pegboard, using dominant hand, measured in a single standard score. | ClinicalTrials.gov |
| Other | Pulmonary Function | Baseline | Participants will complete pulmonary function tests (PFTs) as part of their standard on-campus SJLIFE visit. PFTs will be performed in a single laboratory according to the American Thoracic Society task force guidelines. PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO). The observed values of each survivor for forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), total lung capacity (TLC), and DLCOcorr will be compared with those predicted for the patient's age, race, gender, and height based on reference equations. | ClinicalTrials.gov |
| Other | Echocardiogram | Baseline | Participants will complete an echocardiogram as part of their standard SJLIFE visit. All echocardiograms will be performed using a General Electric VIVID-7. The LV volume, mass and EF will be calculated using the recommendations of the American Society of Echocardiography. | 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 8
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 | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Other 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)