NCT03730194

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

Completed NA Results posted Last updated 22 December 2023

What this trial tests

NA trial testing Melatonin in Autism Spectrum Disorder in 40 participants. Completed in 1 November 2021.

Timeline

31 May 2019

Primary endpoint
1 November 2021

1 November 2021

Quick facts

Lead sponsor	University of Nebraska
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	31 May 2019
Primary completion	1 November 2021
Estimated completion	1 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Melatonin (MELATONIN) — full drug profile →
• Bedtime Bank

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
• Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

University of Nebraska

Who can join

Adults 10 to 18, any sex, with Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Actigraphy (Total Sleep Time) Primary · 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.

Baseline

Group	Value	95% CI
First Stage Melatonin	7.08	± 0.50
First Stage Bedtime Bank	7.03	± 1.01

Week 4

Group	Value	95% CI
First Stage Melatonin	7.16	± 0.42
First Stage Bedtime Bank	7.01	± 0.38

Week 8

Group	Value	95% CI
First Stage Melatonin	7.06	± 0.45
First Stage Bedtime Bank	7.29	± 0.48

AARP- Abbreviated Acceptability Rating Profile Primary · 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

Week 4

Group	Value	95% CI
First Stage Melatonin	38.84	± 7.19
First Stage Bedtime Bank	34.00	± 6.36

Week 8

Group	Value	95% CI
First Stage Melatonin	38.84	± 6.83
First Stage Bedtime Bank	37.89	± 5.49

Urinary Melatonin Secondary · Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.

The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.

Group	Value	95% CI
First Stage Melatonin	81.90	± 43.67
First Stage Bedtime Bank	78.58	± 31.50

PROMIS Pediatric Item Bank Sleep Related Impairment Secondary · Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.

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

Baseline

Group	Value	95% CI
First Stage Melatonin	58.73	± 2.2
First Stage Bedtime Bank	58.37	± 2.3

Week 4

Group	Value	95% CI
First Stage Melatonin	53.87	± 2.74
First Stage Bedtime Bank	53.56	± 2.8

Week 8

Group	Value	95% CI
First Stage Melatonin	52.76	± 2.7
First Stage Bedtime Bank	51.62	± 2.9

PROMIS Pediatric Item Bank Sleep Disturbance Secondary · Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.

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

Baseline

Group	Value	95% CI
First Stage Melatonin	63.37	± 2.5
First Stage Bedtime Bank	64.160	± 2.5

Week 4

Group	Value	95% CI
First Stage Melatonin	59.46	± 2.5
First Stage Bedtime Bank	59.20	± 2.5

Week 8

Group	Value	95% CI
First Stage Melatonin	56.57	± 2.7
First Stage Bedtime Bank	56.65	± 2.6

Cleveland Adolescent Sleepiness Questionnaire (CASQ) Secondary · Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)

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

Baseline

Group	Value	95% CI
First Stage Melatonin	37.70	± 7.994
First Stage Bedtime Bank	41.50	± 10.430

Week 4

Group	Value	95% CI
First Stage Melatonin	35.21	± 8.911
First Stage Bedtime Bank	38.79	± 7.052

Week 8

Group	Value	95% CI
First Stage Melatonin	33.74	± 6.723
First Stage Bedtime Bank	38.42	± 8.952

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Melatonin Only

Serious: 0/27 (0%)

Deaths: 0

Bedtime Bank Only

Serious: 0/26 (0%)

Deaths: 0

Combination (Melatonin+Bedtime Bank)

Serious: 0/13 (0%)

Deaths: 0

Other adverse events (2 terms — click to expand)

Reaction	System	Melatonin Only	Bedtime Bank Only	Combination (Melatonin+Bed…
Mild Dermatitis	Skin and subcutaneous tissue disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03730194 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.