Autism Spectrum DisorderNCT03730194

A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders

A study testing Melatonin and Bedtime Bank in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs). Read more about this study

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
What is being tested?: Melatonin and Bedtime Bank
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 31 May 2019to 1 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 10-18 years and consistently living with parental (or legal guardian) supervision.
Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ>70).
Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.

Who cannot join

Unwillingness to stop melatonin 2 months prior to enrollment in the study.
Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
Adolescents who are not able to take oral medication.
Adolescents who are visually impaired with known inability to detect light.
Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Nebraska Medical Center, Center for Nursing Science
Omaha, Nebraska, 68198-5330

Other trials in United States

About this study

Read the detailed description

The investigators conducted a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (NDDs). Participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute average nightly increase in total sleep time [TST]) was measured at Week 4 and Week 8. Participants who responded (>/= 18 minute average nightly increase in TST) at Week 4 remained on the assigned intervention. Participants who were non-responsive at Week 4 were re-randomized to a different sleep intervention or combined interventions.

Conditions: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
Being tested: Melatonin, Bedtime Bank
Keywords: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance, Melatonin, ASD, ADHD
Medical subject headings: Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MelatoninDietary supplement
Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
Bedtime BankBehavioural
The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.

Study groups in NCT03730194
Study group	Role	What they receive
Melatonin Only	Experimental	In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks). Receives: Dietary Supplement: Melatonin
The Bedtime Bank Only	Experimental	In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks). Receives: Behavioral: Bedtime Bank
Melatonin than Bedtime Bank	Experimental	In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. Receives: Dietary Supplement: Melatonin; Behavioral: Bedtime Bank
Melatonin than Melatonin+Bedtime Bank Combo	Experimental	In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, non-responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. Receives: Dietary Supplement: Melatonin; Behavioral: Bedtime Bank
Bedtime Bank than Melatonin	Experimental	In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. Receives: Dietary Supplement: Melatonin; Behavioral: Bedtime Bank
Bedtime Bank than Bedtime Bank+Melatonin Combo	Experimental	In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, non-responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. Receives: Dietary Supplement: Melatonin; Behavioral: Bedtime Bank

What is being measured

The primary outcome is the main question the study is designed to answer.

Actigraphy (Total Sleep Time)
Objective measure of sleep patterns based on the correlation between sleep-wake state and motor activity. A sleep diary was utilized to guide data analysis.
Measured: To be worn daily for the entirety of the study (9 weeks total). Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)
AARP- Abbreviated Acceptability Rating Profile
Parents completed the Abbreviated Acceptability Rating Profile (AARP), which will be used to indicate minimal treatment acceptability. Parent(s) and adolescent completed a semi-structured interview to discuss treatment acceptability.
Min/Max Values: 8-48 Higher scores=more acceptable/better
Measured: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)

Secondary outcomes (4)

Urinary Melatonin
The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.
Measured: Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.
PROMIS Pediatric Item Bank Sleep Related Impairment
An 8-item questionnaire used to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours.
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). Higher scores=worse sleep related impairment
Measured: Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.
PROMIS Pediatric Item Bank Sleep Disturbance
An 8-item questionnaire used to measure self-reported perceptions of sleep quality, depth, and restoration. This includes perceived difficulties getting to sleep and staying asleep, as well as sleep satisfaction.
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). Higher scores=worse sleep disturbance
Measured: Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
A sixteen-item instrument used to measure daytime sleepiness in adolescents 11-17 years of age.
Score ranges between 16-80. Higher scores would indicate greater sleepiness
Measured: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 20191 Nov 2021

First posted5 Nov 2018
Study start31 May 2019
Primary completion1 Nov 2021
Study completion1 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by University of NebraskaThe 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Model description: The investigators utilized a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study design to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (NDDs). Participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or The Bedtime Bank. Response (\>/= 18 minute average nightly increase in total sleep time \[TST\]) was measured at Week 4 and Week 8. Participants who responded (\>/= 18 minute average nightly increase in TST) at Week 4 remained on the assigned intervention. Participants who were non-responsive at Week 4 were re-randomized to a different sleep intervention or combined interventions.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03730194
Sponsor's protocol ID: 0775-18-FB
Other IDs: 1K01NR017465-01A1
Status last verified: Dec 2023
First submitted: 31 Oct 2018
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
PubMed 22438190
Gruber R, Somerville G, Bergmame L, Fontil L, Paquin S. School-based sleep education program improves sleep and academic performance of school-age children. Sleep Med. 2016 May;21:93-100. doi: 10.1016/j.sleep.2016.01.012. Epub 2016 Feb 15.
PubMed 27448478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
ClinicalTrials.gov ID: NCT03730194
Acronym / sponsor ID: 0775-18-FB
Conditions: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
Keywords: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance, Melatonin, ASD, ADHD
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of NebraskaUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 31 May 2019 (actual)
Primary completion: 1 Nov 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 5 Nov 2018 (actual)
Results: Posted 4 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: The investigators utilized a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study design to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (NDDs). Participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute average nightly increase in total sleep time [TST]) was measured at Week 4 and Week 8. Participants who responded (>/= 18 minute average nightly increase in TST) at Week 4 remained on the assigned intervention. Participants who were non-responsive at Week 4 were re-randomized to a different sleep intervention or combined interventions.

Arm	Type	Receives
Melatonin Only	Experimental	Dietary Supplement: MelatoninIn stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
The Bedtime Bank Only	Experimental	Behavioral: Bedtime BankIn stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
Melatonin than Bedtime Bank	Experimental	Dietary Supplement: Melatonin, Behavioral: Bedtime BankIn stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
Melatonin than Melatonin+Bedtime Bank Combo	Experimental	Dietary Supplement: Melatonin, Behavioral: Bedtime BankIn stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, non-responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
Bedtime Bank than Melatonin	Experimental	Dietary Supplement: Melatonin, Behavioral: Bedtime BankIn stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
Bedtime Bank than Bedtime Bank+Melatonin Combo	Experimental	Dietary Supplement: Melatonin, Behavioral: Bedtime BankIn stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, non-responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Age 10-18 years and consistently living with parental (or legal guardian) supervision.
Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ>70).
Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.

Key exclusion criteria (6 listed)

Unwillingness to stop melatonin 2 months prior to enrollment in the study.
Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
Adolescents who are not able to take oral medication.
Adolescents who are visually impaired with known inability to detect light.
Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).

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
MelatoninMelatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime	Dietary supplement	Bedtime Bank than Bedtime Bank+Melatonin Combo, Bedtime Bank than Melatonin, Melatonin Only, Melatonin than Bedtime Bank, Melatonin than Melatonin+Bedtime Bank Combo
Bedtime BankThe Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.	Behavioural	Bedtime Bank than Bedtime Bank+Melatonin Combo, Bedtime Bank than Melatonin, Melatonin than Bedtime Bank, Melatonin than Melatonin+Bedtime Bank Combo, The Bedtime Bank Only

Primary outcome

Actigraphy (Total Sleep Time)
Time frame: To be worn daily for the entirety of the study (9 weeks total). Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)
Objective measure of sleep patterns based on the correlation between sleep-wake state and motor activity. A sleep diary was utilized to guide data analysis.
AARP- Abbreviated Acceptability Rating Profile
Time frame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)
Parents completed the Abbreviated Acceptability Rating Profile (AARP), which will be used to indicate minimal treatment acceptability. Parent(s) and adolescent completed a semi-structured interview to discuss treatment acceptability. Min/Max Values: 8-48 Higher scores=more acceptable/better

4 secondary outcomes

Urinary Melatonin
Time frame: Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.
PROMIS Pediatric Item Bank Sleep Related Impairment
Time frame: Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.
PROMIS Pediatric Item Bank Sleep Disturbance
Time frame: Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
Time frame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)

Results and safety

Results posted to the registry on 4 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Melatonin Only	20	16
Bedtime Bank Only	20	16
Melatonin Then Bedtime Bank	0	0
Melatonin Then Melatonin+Bedtime Bank Combo	0	0
Bedtime Bank Then Melatonin	0	0
Bedtime Bank Then Bedtime Bank+Melatonin Combo	0	0

Primary outcome: Actigraphy (Total Sleep Time)

Time frame: To be worn daily for the entirety of the study (9 weeks total). Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8). Mean (Standard Deviation). Unit: Time (hours.minutes of nightly sleep)

Measure	First Stage Melatonin n = 19	First Stage Bedtime Bank n = 20
Baseline	7.08 (0.50)	7.03 (1.01)
Week 4	7.16 (0.42)	7.01 (0.38)
Week 8	7.06 (0.45)	7.29 (0.48)

Population analysed: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8). Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders.

Primary outcome: AARP- Abbreviated Acceptability Rating Profile

Time frame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8). Mean (Standard Deviation). Unit: units on a scale

Measure	First Stage Melatonin n = 19	First Stage Bedtime Bank n = 18
Week 4	38.84 (7.19)	34.00 (6.36)
Week 8	38.84 (6.83)	37.89 (5.49)

Population analysed: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8). Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored by the Data Safety Monitoring Board at the University of Nebraska Medical Center in conjunction with IRB protocols. Adverse event data were collected over the 2 years of the study (2019-2021) from initial consent to end of the trials (approximately 9 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Melatonin Only	0 of 27 (0%)	3 of 27 (11.1%)
Bedtime Bank Only	0 of 26 (0%)	2 of 26 (7.7%)
Combination (Melatonin+Bedtime Bank)	0 of 13 (0%)	0 of 13 (0%)

Limitations and caveats (from the sponsor): This K01 study was a pilot feasibility SMART design, which will inform implementation of a future full-scale SMART design to construct adaptive biobehavioral sleep intervention strategies. Pilot SMARTs provide preliminary knowledge about the direction of the effect, and the aims focus on preliminary knowledge; however, conducting formal tests of outcomes or effect size estimation is not justified. The COVID-19 pandemic began March 2020, and may have impact on study results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22438190Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
Background: PubMed 27448478Gruber R, Somerville G, Bergmame L, Fontil L, Paquin S. School-based sleep education program improves sleep and academic performance of school-age children. Sleep Med. 2016 May;21:93-100. doi: 10.1016/j.sleep.2016.01.012. Epub 2016 Feb 15.
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.

Alyson E Hanish, PhD, MSN, RN principal investigator

University of Nebraska

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin and Bedtime Bank in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by University of Nebraska 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Dec 2023. 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?

Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Actigraphy (Total Sleep Time) (time frame: To be worn daily for the entirety of the study (9 weeks total). Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730194, which also lists 2 linked publications.

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 22 Dec 2023.