ALL, AdultNCT05480904
Characterizing Sleep Among Long-term Survivors of Childhood Cancer
An observational study of ALL, Adult and CNS Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The patients are being asked to take part in this clinical trial because they received cancer treatment as a child at St. Jude. The study comprehensively examines sleep among three distinct diagnostic groups of survivors in the SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALL, Adult, CNS Tumor, Solid Tumor
- What is being tested?
- Neurocognitive (Thinking) Testing, CNS Vital Signs (Thinking) Testing and Health Questionnaires, Sleep Surveys & Sleep Diary
- Type of treatment
- Medical device
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to Jan 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- Participant in SJLIFE and > 5 years from diagnosis.
- >18 years of age at time of enrollment.
- Diagnosed with ALL (treated with CRT or chemotherapy only) or CNS tumors (posterior fossa tumors or supratentorial tumors) or non-CNS solid tumors (with abdominal or chest radiation or bilateral retinoblastoma survivors).
- Participant was less than 21 years of age at time of diagnosis.
- Speaks and understands English (polysomnography device speaks to patients only in English).
- Remote participant must have Wi-Fi access
Who cannot join
- Estimated intelligence score <80.
- Currently prescribed an intervention for a sleep disorder.
- Survivor of craniopharyngioma.
- Survivor of Hodgkin Lymphoma.
- Relapsed or treated with hematopoietic stem cell therapy.
- Brain injury unrelated to cancer diagnosis or therapy.
- Pulmonary injury unrelated to cancer diagnosis or therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
The patients are being asked to take part in this clinical trial because they received cancer treatment as a child at St. Jude. The study comprehensively examines sleep among three distinct diagnostic groups of survivors in the SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors.
Primary Objective
The primary aim of this protocol is to estimate the prevalence of various sleep disorders among long-term survivors of childhood ALL, CNS tumors, and non- CNS solid tumors.
Exploratory Objective
The exploratory objective of the study is to explore associations between the prevalence of sleep disorders and clinical outcomes collected in SJLIFE.
Read the detailed description
A cross-sectional pilot study that will enroll participants for on-campus or remote study activities. The investigators anticipate a targeted evaluable accrual of 120, 40 within each of the three groups identified above. The plan is to employ remote polysomnography and surveys to assess patterns of sleep disorders. These assessments could be done in the homes of survivors or during campus visits.
- Conditions
- ALL, Adult, CNS Tumor, Solid Tumor
- Being tested
- Neurocognitive (Thinking) Testing, CNS Vital Signs (Thinking) Testing, Health Questionnaires, Sleep Surveys & Sleep Diary, Echocardiography/EKG, Pulmonary Function
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive (Thinking) TestingOther
Intelligence: WASI-II 20 min; Sustained Attention:
Conners Continuous Performance Test 3rd ED. 15 min; Memory: California Verbal Learning Test 2nd Ed. 20 min; Visual Selective Reminding 7 min; Processing Speed:Coding/Digit Symbol 3 min; Grooved Pegboard 5 min; Executive Function: Trail Making Test 5 min; Verbal Fluency Test 3 min; Digit Span 5 min; Visuospatial: Rey Complex Figure 10 min; Functional Behavior: CCSS Neurocognitive Questionnaire 5 min.
CNS Vital Signs (Thinking) TestingDiagnostic test
Attention: Continuous Performance Task 5 mins Processing Speed: Symbol Digit Test 4 mins Executive Function: Shifting Attention 3 min and Stroop Test 5 mins
Health Questionnaires, Sleep Surveys & Sleep DiaryOther
The participant will be asked to complete the sleep surveys and sleep diary, FACIT fatigue, and CSALTS Pain Survey These questionnaires will take about 29 minutes to complete. The sleep diary is completed at the time the participant wears the sleep device.
Echocardiography/EKGDiagnostic test
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
Pulmonary FunctionDiagnostic test
PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO).
Remote PolysomnographyDevice
Also called Sleep Profiler PSG2-Overnight Sleep Study
The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.
Physical FunctionDiagnostic test
This is a test of how your heart and lungs respond to exercise.
| Study group | Role | What they receive |
|---|---|---|
| On campus | SJLIFE Study Campus Visit Receives: Other: Neurocognitive (Thinking) Testing; Other: Health Questionnaires, Sleep Surveys & Sleep Diary; Diagnostic Test: Echocardiography/EKG; Diagnostic Test: Pulmonary Function; Device: Remote Polysomnography; Diagnostic Test: Physical Function | |
| Remote | SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors Receives: Diagnostic Test: CNS Vital Signs (Thinking) Testing; Other: Health Questionnaires, Sleep Surveys & Sleep Diary; Device: Remote Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
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.
Measured: Baseline
CSALTS Sleep Survey
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.
Measured: Baseline
Morningness-Eveningness Questionnaire (MEQ)
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).
Measured: Baseline
Circadian Type Inventory (CTI)
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.
Measured: Baseline
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)
fatigue scale is a short 13-item tool that provides a single measure of an individual's level of fatigue during a usual day.
Measured: Baseline
CSALTS Pain Survey
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."
Measured: Baseline for 2 nights
Polysomnography Evaluation (Sleep Profiler PSG2 or WatchPAT)
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
Measured: Baseline
Secondary outcomes (5)
Sustained Attention -Conners Continuous Performance Test 3rd Ed or CNS-VS CPT.
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.
Measured: Baseline
Memory-California Verbal Learning Test 2nd Ed.
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.
Measured: Baseline
Executive Functions -Trail Making Test or CNS-VS Shifting Attention Test
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.
Measured: Baseline
Executive Functions- Verbal Fluency Test Controlled Oral Word Association (COWA) or CNS-VS Stroop Test
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
Measured: Baseline
Executive Functions -Digit Span Backward
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start17 Apr 2023
- Primary completion29 Apr 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, AdultStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Krull, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480904
- Sponsor's protocol ID
- CSALTS
- Other IDs
- NCI-2022-08555
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Sleep Among Long-term Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT05480904
- Acronym / sponsor ID
- CSALTS
- Conditions
- ALL, Adult, CNS Tumor, Solid Tumor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Jul 2022 (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 patients are being asked to take part in this clinical trial because they received cancer treatment as a child at St. Jude. The study comprehensively examines sleep among three distinct diagnostic groups of survivors in the SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors.
Primary Objective
The primary aim of this protocol is to estimate the prevalence of various sleep disorders among long-term survivors of childhood ALL, CNS tumors, and non- CNS solid tumors.
Exploratory Objective
The exploratory objective of the study is to explore associations between the prevalence of sleep disorders and clinical outcomes collected in SJLIFE.
Detailed description
A cross-sectional pilot study that will enroll participants for on-campus or remote study activities. The investigators anticipate a targeted evaluable accrual of 120, 40 within each of the three groups identified above. The plan is to employ remote polysomnography and surveys to assess patterns of sleep disorders. These assessments could be done in the homes of survivors or during campus visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On campus | – | Other: Neurocognitive (Thinking) Testing, Other: Health Questionnaires, Sleep Surveys & Sleep Diary, Diagnostic Test: Echocardiography/EKG, Diagnostic Test: Pulmonary Function, Device: Remote Polysomnography, Diagnostic Test: Physical FunctionSJLIFE Study Campus Visit |
| Remote | – | Diagnostic Test: CNS Vital Signs (Thinking) Testing, Other: Health Questionnaires, Sleep Surveys & Sleep Diary, Device: Remote PolysomnographySJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (6 listed)
- Participant in SJLIFE and > 5 years from diagnosis.
- >18 years of age at time of enrollment.
- Diagnosed with ALL (treated with CRT or chemotherapy only) or CNS tumors (posterior fossa tumors or supratentorial tumors) or non-CNS solid tumors (with abdominal or chest radiation or bilateral retinoblastoma survivors).
- Participant was less than 21 years of age at time of diagnosis.
- Speaks and understands English (polysomnography device speaks to patients only in English).
Key exclusion criteria (7 listed)
- Estimated intelligence score <80.
- Currently prescribed an intervention for a sleep disorder.
- Survivor of craniopharyngioma.
- Survivor of Hodgkin Lymphoma.
- Relapsed or treated with hematopoietic stem cell therapy.
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 |
|---|---|---|
| Neurocognitive (Thinking) TestingIntelligence: WASI-II 20 min; Sustained Attention: Conners Continuous Performance Test 3rd ED. 15 min; Memory: California Verbal Learning Test 2nd Ed. 20 min; Visual Selective Reminding 7 min; Processing Speed:Coding/Digit Symbol 3 min; Grooved Pegboard 5 min; Executive Function: Trail Making Test 5 min; Verbal Fluency Test 3 min; Digit Span 5 min; Visuospatial: Rey Complex Figure 10 min; Functional Behavior: CCSS Neurocognitive Questionnaire 5 min. | Other | On campus |
| CNS Vital Signs (Thinking) TestingAttention: Continuous Performance Task 5 mins Processing Speed: Symbol Digit Test 4 mins Executive Function: Shifting Attention 3 min and Stroop Test 5 mins | Diagnostic test | Remote |
| Health Questionnaires, Sleep Surveys & Sleep DiaryThe participant will be asked to complete the sleep surveys and sleep diary, FACIT fatigue, and CSALTS Pain Survey These questionnaires will take about 29 minutes to complete. The sleep diary is completed at the time the participant wears the sleep device. | Other | On campus, Remote |
| Echocardiography/EKGAll 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 | Diagnostic test | On campus |
| Pulmonary FunctionPFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO). | Diagnostic test | On campus |
| Remote PolysomnographyAlso: Sleep Profiler PSG2-Overnight Sleep StudyThe Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders. | Device | On campus, Remote |
| Physical FunctionThis is a test of how your heart and lungs respond to exercise. | Diagnostic test | On campus |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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.
CSALTS Sleep Survey
Time frame: 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.
Morningness-Eveningness Questionnaire (MEQ)
Time frame: 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).
Circadian Type Inventory (CTI)
Time frame: 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.
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)
Time frame: 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.
CSALTS Pain Survey
Time frame: 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."
Polysomnography Evaluation (Sleep Profiler PSG2 or WatchPAT)
Time frame: 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
5 secondary outcomes
Sustained Attention -Conners Continuous Performance Test 3rd Ed or CNS-VS CPT.
Time frame: Baseline
Memory-California Verbal Learning Test 2nd Ed.
Time frame: Baseline
Executive Functions -Trail Making Test or CNS-VS Shifting Attention Test
Time frame: Baseline
Executive Functions- Verbal Fluency Test Controlled Oral Word Association (COWA) or CNS-VS Stroop Test
Time frame: Baseline
Executive Functions -Digit Span Backward
Time frame: Baseline
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 Aug 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kevin Krull, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALL, Adult and CNS Tumor, run by St. Jude Children's Research Hospital 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 6 inclusion and 7 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 19 Aug 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?
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?
Insomnia Severity Index (ISI) (time frame: Baseline). The study lists 7 primary outcomes in all. 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 Aug 2026.