ADHDPhase 1/2NCT07061470
A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep
A Phase 1/2 study testing Ferrous Sulfate in people with ADHD and Sleep Problems, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- ADHD, Sleep Problems
- What is being tested?
- Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 31 Jul 2027
- Phase
- Phase 1/2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinically diagnosed with ADHD
- have blood ferritin level below 50ng/mL
- have parent- or self-reported restless sleep
Who cannot join
- presence of any chronic medical or genetic condition that could impact iron metabolism
- presence of moderate to severe Obstructive Sleep Apnea
- having received Iron supplementation treatment within the past 3 months
- having blood ferritin level indicative of anemia that requires immediate treatment
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
Kennedy Krieger Institute
Baltimore, Maryland, 21231
Alison E Pritchard, PhD, 443-904-2488, pritchard@kennedykrieger.org
About this study
Official title: RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit/Hyperactivity Disorder, Phase II
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:
Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo?
Read more
Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.
Participants will:
- Take iron supplements every day for 3 months
- Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention
- Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment
Read the detailed description
Study Population Seventy youth (n=70) will be recruited for participation in the proposed study. Youth meeting eligibility criteria will be recruited through Kennedy Krieger Institute's Sleep Disorders Clinic and Center for Neuropsychological and Psychological Assessment (CNaP). Recruitment will be accomplished by posting flyers with study information at the clinics, by reviewing medical record information of upcoming patients to determine potential eligibility, and by asking clinicians to discuss the study with their patients who may be eligible and their caregivers.
Study Design A double-blind, placebo-controlled randomized superiority trial design will be used in this study. Seventy participants will be assigned to treatment and control conditions using permuted block randomization, based on sequential enrollment and equal allocation to study conditions. Both the participant and members of the study team involved in data collection or outcomes assessment will be blinded to the participant's treatment assignment. The treatment interval for the study will be 3 months, which has been sufficient in previous studies to allow for treatment effects to be observed. Pre-treatment and post-treatment, the following data will be collected for each participant:
- a complete iron blood panel; 2) 14 consecutive nights of actigraphy monitoring using the RestEaze device at home; 3) parent- or self-ratings of sleep quality over the same 14 nights on which the device is worn; 4) ratings of ADHD symptoms(ADHD-RS-V5) completed by parent and teacher; 5) ratings of sleep problems completed by parent; and 6) neuropsychological testing of attention.
Study Treatment Iron supplementation. The NatureMade brand of iron supplement will be administered to all participants in the treatment condition to minimize variability in concentration of the active ingredients across brands/preparations of iron supplements. This brand of iron supplement is independently verified by United States Pharmacopeia (USP), which conducts rigorous evaluation and monitoring of dietary supplements to ensure that they contain the necessary ingredients at the dosages that are claimed by the manufacturer. Dosing will be determined for each participant by the study physician based on weight. All NatureMade pills will be over encapsulated by the Johns Hopkins Investigational Drug Service to ensure treatment blinding for patients. At the conclusion of study participation, participants will work with their physician to determine whether iron supplementation should be continued.
Placebo. Placebo pills will be manufactured by the Johns Hopkins Investigational Drug Service to match the appearance of the over encapsulated NatureMade pills. At the conclusion of the study, participants assigned to the placebo condition whose blood ferritin levels remain under 50ng/mL will be offered a free 3-month supply of the NatureMade active iron treatment.
Treatment adherence. To monitor treatment adherence, all pills (iron and placebo) will be provided to participants in MEMS cap smart pill bottles. Each plain bottle will be labeled with the participant's name and directions for use and will have a MEMS cap which records the date and time each time the cap is removed from the bottle. These data will be stored, linked to the participant's ID number, in the smart pill bottle software and then downloaded to a secure local server within Kennedy Krieger Institute. These data will allow for daily monitoring of treatment adherence by study personnel, which will provide the opportunity for study personnel to reach out to the participant to encourage compliance or troubleshoot any problems throughout each child's study participation. Participants will be removed from the study prior to completion if they experience significant adverse effects of the treatment, if they do not adhere to treatment or initiate other confounding treatments, or at the request of the patient/family.
Measurement of Peripheral Iron Concentrations. Peripheral iron concentrations will be obtained as part of routine clinical care pre- and post-iron supplementation. Standard indicators of iron availability and storage will be tested with a fasting complete blood count (CBC), serum iron, serum ferritin, total iron binding capacity (TIBC) and transferrin level.
Study Outcomes Study outcomes are reported in the Outcome Measures section.
- Conditions
- ADHD, Sleep Problems
- Being tested
- Ferrous Sulfate, Placebo
- Keywords
- ADHD, iron supplements, sleep, restlessness, attention, restless legs syndrome
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Parasomnias, Psychomotor Agitation, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDietary supplement
Dosing of the iron supplement will be based on weight.
PlaceboOther
Placebo pills will be provided to participants in the placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Iron supplementation arm | Experimental | Participants in the iron supplementation arm will receive 3 months of iron supplementation treatment Receives: Dietary Supplement: Ferrous Sulfate |
| Placebo arm | Placebo comparator | Participants in the placebo arm will receive 3 months of placebo treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Sleep efficiency refers to the proportion of time in bed spent sleeping and is measured via actigraphy monitoring. Higher scores indicate more efficient/better sleep.
Measured: Sleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Secondary outcomes (11)
Total sleep time
Total sleep time in minutes as measured by actigraphy. Higher scores indicate more time asleep.
Measured: These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Wake after sleep onset
Number of minutes spent awake between falling asleep at night and getting up in the morning, as measured by actigraphy. Higher scores on this measure are indicative of greater difficulty staying asleep through the night.
Measured: These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Latency to sleep onset
Number of minutes from laying down in bed for the night to falling asleep, measured by actigraphy. Higher scores on this measure will indicate longer times to fall asleep.
Measured: Assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Attention Deficit Hyperactivity Disorder-Rating Scale-V, parent version
Parent rating of child's ADHD symptoms; raw scores will be calculated by summing all items and will range from 0-54; higher scores indicate more severe ADHD symptoms.
Measured: Completed at baseline and again within 2 weeks post-treatment.
Attention Deficit Hyperactivity Disorder-Rating Scale-V, self report
Youth self-report of ADHD symptoms; raw scores will be calculated by summing all items and will range from 0-54; higher scores indicate more severe ADHD symptoms.
Measured: Completed at baseline and again within 2 weeks post-treatment.
Conners Continuous Performance Test (CPT), 3rd edition
This computer-administered go/no-go test was designed to measure response preparation, sustained attention, and inhibitory control. Ex-Gaussian decomposition of response time variability will the primary indicator of sustained attention, and number of omission and commission errors will serve as indices of cognitive control. The CPT-3 is normed for children ages 8 and up and takes 14 minutes to complete. T-scores (min = 10, max = 90) comparing the participant's performance to normative data will be used. Higher T-scores indicate worse sustained attention, response preparation, and inhibitory control.
Measured: Completed at baseline and again within 2 weeks post-treatment.
Children's Sleep Habits Questionnaire
The CSHQ is a 45-item parent-report questionnaire assessing eight domains of a child's sleep: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep-Disordered Breathing, and Daytime Sleepiness. The measure has demonstrated adequate psychometric properties; except for criterion-related validity. These common areas of concern for children's sleep will be rated by parents on a 3-point Likert scale once pre-treatment and again post-treatment. Ratings on this measure will be used to evaluate sleep-related concerns other than restlessness, as well as change in these concerns with treatment. The total raw score will be calculated by summing all item scores (minimum = 0, maximum = 135) with higher scores indicating more sleep problems.
Measured: Completed at baseline and again within 2 weeks post-treatment.
Sleep Quality Scale
The SQS is a single item measure of overall sleep quality. Respondents are asked to answer to the question "How would you rate your sleep quality overall last night?" using a 0-10 scale where 0 represents "terrible," 1-3 represent "poor," 4-6 represent "fair," 7-9 represent "good," and 10 represents "excellent." Participants in the present study will be asked to rate their sleep each night during the 14 nights on which they are wearing the RestEaze bands pre- and post- treatment.
Measured: Completed daily for 2 weeks at baseline and then again daily for 2 weeks post-treatment.
Wechsler Intelligence Measures, Cancellation Subtest
The Cancellation subtest from the Wechsler Intelligence measures will be used as an index of focused attention. This subtest requires the child to mark target objects and ignore distracters in both a structured and a random array. It takes approximately 5 minutes to administer. Age-appropriate versions of the same task are available for children ages 6-16 (WISC-V), and ages 17+ (WAIS-IV). Norm-referenced scaled scores will be reported (min = 1, max = 19), with higher scores indicating better focused attention.
Measured: Completed at baseline and again within 2 weeks post-treatment.
NIH Toolbox Flanker Task
The flanker task is a measure of attention and inhibitory control. For this task, the child is required to focus attention on a specified stimulus, while inhibiting attention to stimuli positioned on either side of the specified stimulus. The age-adjusted scaled score for this task combines reaction time and accuracy. This task takes less than 10 minutes to administer and is appropriate for children ages 3 and up. Norm-referenced Standard Scores (min = 55, max = 145) will be reported, with higher scores indicating better cognitive flexibility.
Measured: Completed at baseline and again within 2 weeks post-treatment.
NIH Toolbox Dimensional Change Card Sort task
This task is a measure of cognitive flexibility and control. It requires the child to matcha series of pictures first on one dimension (e.g., color), then on another dimension (e.g., shape) with only accuracy feedback as a guide after each trial (no explicit statement of the matching rule). The age-adjusted scaled score for this task combines reaction time and accuracy. This task, recommended for children ages 3 and up, takes less than 10 minutes to administer. Norm-referenced Standard Scores (min = 55, max = 145) will be reported, with higher scores indicating better cognitive flexibility.
Measured: Completed at baseline and again within 2 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Mar 2027 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison E Pritchard, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061470
- Sponsor's protocol ID
- IRB00511528
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit/Hyperactivity Disorder, Phase II
- ClinicalTrials.gov ID
- NCT07061470
- Acronym / sponsor ID
- IRB00511528
- Conditions
- ADHD, Sleep Problems
- Keywords
- ADHD, iron supplements, sleep, restlessness, attention, restless legs syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Jul 2025 (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 goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:
Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo?
Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.
Participants will:
- Take iron supplements every day for 3 months
- Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention
- Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment
Detailed description
Study Population Seventy youth (n=70) will be recruited for participation in the proposed study. Youth meeting eligibility criteria will be recruited through Kennedy Krieger Institute's Sleep Disorders Clinic and Center for Neuropsychological and Psychological Assessment (CNaP). Recruitment will be accomplished by posting flyers with study information at the clinics, by reviewing medical record information of upcoming patients to determine potential eligibility, and by asking clinicians to discuss the study with their patients who may be eligible and their caregivers.
Study Design A double-blind, placebo-controlled randomized superiority trial design will be used in this study. Seventy participants will be assigned to treatment and control conditions using permuted block randomization, based on sequential enrollment and equal allocation to study conditions. Both the participant and members of the study team involved in data collection or outcomes assessment will be blinded to the participant's treatment assignment. The treatment interval for the study will be 3 months, which has been sufficient in previous studies to allow for treatment effects to be observed. Pre-treatment and post-treatment, the following data will be collected for each participant:
- a complete iron blood panel; 2) 14 consecutive nights of actigraphy monitoring using the RestEaze device at home; 3) parent- or self-ratings of sleep quality over the same 14 nights on which the device is worn; 4) ratings of ADHD symptoms(ADHD-RS-V5) completed by parent and teacher; 5) ratings of sleep problems completed by parent; and 6) neuropsychological testing of attention.
Study Treatment Iron supplementation. The NatureMade brand of iron supplement will be administered to all participants in the treatment condition to minimize variability in concentration of the active ingredients across brands/preparations of iron supplements. This brand of iron supplement is independently verified by United States Pharmacopeia (USP), which conducts rigorous evaluation and monitoring of dietary supplements to ensure that they contain the necessary ingredients at the dosages that are claimed by the manufacturer. Dosing will be determined for each participant by the study physician based on weight. All NatureMade pills will be over encapsulated by the Johns Hopkins Investigational Drug Service to ensure treatment blinding for patients. At the conclusion of study participation, participants will work with their physician to determine whether iron supplementation should be continued.
Placebo. Placebo pills will be manufactured by the Johns Hopkins Investigational Drug Service to match the appearance of the over encapsulated NatureMade pills. At the conclusion of the study, participants assigned to the placebo condition whose blood ferritin levels remain under 50ng/mL will be offered a free 3-month supply of the NatureMade active iron treatment.
Treatment adherence. To monitor treatment adherence, all pills (iron and placebo) will be provided to participants in MEMS cap smart pill bottles. Each plain bottle will be labeled with the participant's name and directions for use and will have a MEMS cap which records the date and time each time the cap is removed from the bottle. These data will be stored, linked to the participant's ID number, in the smart pill bottle software and then downloaded to a secure local server within Kennedy Krieger Institute. These data will allow for daily monitoring of treatment adherence by study personnel, which will provide the opportunity for study personnel to reach out to the participant to encourage compliance or troubleshoot any problems throughout each child's study participation. Participants will be removed from the study prior to completion if they experience significant adverse effects of the treatment, if they do not adhere to treatment or initiate other confounding treatments, or at the request of the patient/family.
Measurement of Peripheral Iron Concentrations. Peripheral iron concentrations will be obtained as part of routine clinical care pre- and post-iron supplementation. Standard indicators of iron availability and storage will be tested with a fasting complete blood count (CBC), serum iron, serum ferritin, total iron binding capacity (TIBC) and transferrin level.
Study Outcomes Study outcomes are reported in the Outcome Measures section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron supplementation arm | Experimental | Dietary Supplement: Ferrous SulfateParticipants in the iron supplementation arm will receive 3 months of iron supplementation treatment |
| Placebo arm | Placebo comparator | Other: PlaceboParticipants in the placebo arm will receive 3 months of placebo treatment |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- clinically diagnosed with ADHD
- have blood ferritin level below 50ng/mL
- have parent- or self-reported restless sleep
Key exclusion criteria (4 listed)
- presence of any chronic medical or genetic condition that could impact iron metabolism
- presence of moderate to severe Obstructive Sleep Apnea
- having received Iron supplementation treatment within the past 3 months
- having blood ferritin level indicative of anemia that requires immediate treatment
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 |
|---|---|---|
| Ferrous SulfateDosing of the iron supplement will be based on weight. | Dietary supplement | Iron supplementation arm |
| PlaceboPlacebo pills will be provided to participants in the placebo arm | Other | Placebo arm |
Primary outcome
Sleep Efficiency
Time frame: Sleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Sleep efficiency refers to the proportion of time in bed spent sleeping and is measured via actigraphy monitoring. Higher scores indicate more efficient/better sleep.
11 secondary outcomes
Total sleep time
Time frame: These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Wake after sleep onset
Time frame: These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Latency to sleep onset
Time frame: Assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Attention Deficit Hyperactivity Disorder-Rating Scale-V, parent version
Time frame: Completed at baseline and again within 2 weeks post-treatment.
Attention Deficit Hyperactivity Disorder-Rating Scale-V, self report
Time frame: Completed at baseline and again within 2 weeks post-treatment.
Conners Continuous Performance Test (CPT), 3rd edition
Time frame: Completed at baseline and again within 2 weeks post-treatment.
Children's Sleep Habits Questionnaire
Time frame: Completed at baseline and again within 2 weeks post-treatment.
Sleep Quality Scale
Time frame: Completed daily for 2 weeks at baseline and then again daily for 2 weeks post-treatment.
Wechsler Intelligence Measures, Cancellation Subtest
Time frame: Completed at baseline and again within 2 weeks post-treatment.
NIH Toolbox Flanker Task
Time frame: Completed at baseline and again within 2 weeks post-treatment.
NIH Toolbox Dimensional Change Card Sort task
Time frame: Completed at baseline and again within 2 weeks post-treatment.
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 4 May 2026.
- 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.
Alison E Pritchard, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ferrous Sulfate in people with ADHD and Sleep Problems, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alison E Pritchard, PhD (443-904-2488, pritchard@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: Sleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.). 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 4 May 2026.