Trial Outcomes & Findings for A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders (NCT NCT03730194)
NCT ID: NCT03730194
Last Updated: 2023-12-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
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)
Results posted on
2023-12-22
Participant Flow
See uploaded study protocol that includes recruitment details.
Participant milestones
| Measure |
Melatonin Only
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).
|
Bedtime Bank Only
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).
|
Melatonin Then Bedtime Bank
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.
|
Melatonin Then Melatonin+Bedtime Bank Combo
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.
|
Bedtime Bank Then Melatonin
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.
|
Bedtime Bank Then Bedtime Bank+Melatonin Combo
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 ill take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
|
|---|---|---|---|---|---|---|
|
First Stage Treatment
STARTED
|
20
|
20
|
0
|
0
|
0
|
0
|
|
First Stage Treatment
COMPLETED
|
16
|
16
|
0
|
0
|
0
|
0
|
|
First Stage Treatment
NOT COMPLETED
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Second Stage Treatment
STARTED
|
7
|
5
|
6
|
6
|
7
|
7
|
|
Second Stage Treatment
COMPLETED
|
7
|
5
|
6
|
6
|
7
|
7
|
|
Second Stage Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Melatonin Only
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).
|
Bedtime Bank Only
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).
|
Melatonin Then Bedtime Bank
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.
|
Melatonin Then Melatonin+Bedtime Bank Combo
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.
|
Bedtime Bank Then Melatonin
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.
|
Bedtime Bank Then Bedtime Bank+Melatonin Combo
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 ill take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
|
|---|---|---|---|---|---|---|
|
First Stage Treatment
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
First Stage Treatment
Protocol Violation
|
3
|
3
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Baseline characteristics by cohort
| Measure |
First Stage Melatonin
n=20 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=20 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13.45 years
STANDARD_DEVIATION 2.95 • n=5 Participants
|
13.00 years
STANDARD_DEVIATION 2.05 • n=7 Participants
|
13.23 years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Diagnosis
Autism (with or without ADHD)
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diagnosis
ADHD only
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
First Stage Melatonin
n=19 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=20 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
|---|---|---|
|
Actigraphy (Total Sleep Time)
Baseline
|
7.08 Time (hours.minutes of nightly sleep)
Standard Deviation 0.50
|
7.03 Time (hours.minutes of nightly sleep)
Standard Deviation 1.01
|
|
Actigraphy (Total Sleep Time)
Week 4
|
7.16 Time (hours.minutes of nightly sleep)
Standard Deviation 0.42
|
7.01 Time (hours.minutes of nightly sleep)
Standard Deviation 0.38
|
|
Actigraphy (Total Sleep Time)
Week 8
|
7.06 Time (hours.minutes of nightly sleep)
Standard Deviation 0.45
|
7.29 Time (hours.minutes of nightly sleep)
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)Population: 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.
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
Outcome measures
| Measure |
First Stage Melatonin
n=19 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=18 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
|---|---|---|
|
AARP- Abbreviated Acceptability Rating Profile
Week 4
|
38.84 units on a scale
Standard Deviation 7.19
|
34.00 units on a scale
Standard Deviation 6.36
|
|
AARP- Abbreviated Acceptability Rating Profile
Week 8
|
38.84 units on a scale
Standard Deviation 6.83
|
37.89 units on a scale
Standard Deviation 5.49
|
SECONDARY outcome
Timeframe: Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.Population: First morning void urinary 6-sulphatoxymelatonin (Urine 6SM). Urine 6SM concentrations were expressed in ng per mg of creatinine (ng/mg Cr) to control for renal function and dilution of urine.
The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.
Outcome measures
| Measure |
First Stage Melatonin
n=19 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=20 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
|---|---|---|
|
Urinary Melatonin
|
81.90 ng/mg Cr
Standard Deviation 43.67
|
78.58 ng/mg Cr
Standard Deviation 31.50
|
SECONDARY outcome
Timeframe: Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.Population: Baseline, Week 4, \& Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score. Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders.
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
Outcome measures
| Measure |
First Stage Melatonin
n=20 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=20 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
|---|---|---|
|
PROMIS Pediatric Item Bank Sleep Related Impairment
Baseline
|
58.73 T-score
Standard Error 2.2
|
58.37 T-score
Standard Error 2.3
|
|
PROMIS Pediatric Item Bank Sleep Related Impairment
Week 4
|
53.87 T-score
Standard Error 2.74
|
53.56 T-score
Standard Error 2.8
|
|
PROMIS Pediatric Item Bank Sleep Related Impairment
Week 8
|
52.76 T-score
Standard Error 2.7
|
51.62 T-score
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.Population: Baseline, Week 4, \& Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE. Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders.
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
Outcome measures
| Measure |
First Stage Melatonin
n=20 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=20 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
|---|---|---|
|
PROMIS Pediatric Item Bank Sleep Disturbance
Baseline
|
63.37 T score
Standard Error 2.5
|
64.160 T score
Standard Error 2.5
|
|
PROMIS Pediatric Item Bank Sleep Disturbance
Week 4
|
59.46 T score
Standard Error 2.5
|
59.20 T score
Standard Error 2.5
|
|
PROMIS Pediatric Item Bank Sleep Disturbance
Week 8
|
56.57 T score
Standard Error 2.7
|
56.65 T score
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)Population: 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.
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
Outcome measures
| Measure |
First Stage Melatonin
n=20 Participants
Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
First Stage Bedtime Bank
n=20 Participants
Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
|---|---|---|
|
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
Baseline
|
37.70 units on a scale
Standard Deviation 7.994
|
41.50 units on a scale
Standard Deviation 10.430
|
|
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
Week 4
|
35.21 units on a scale
Standard Deviation 8.911
|
38.79 units on a scale
Standard Deviation 7.052
|
|
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
Week 8
|
33.74 units on a scale
Standard Deviation 6.723
|
38.42 units on a scale
Standard Deviation 8.952
|
Adverse Events
Melatonin Only
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bedtime Bank Only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Combination (Melatonin+Bedtime Bank)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Melatonin Only
n=27 participants at risk
Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
|
Bedtime Bank Only
n=26 participants at risk
Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Bedtime Bank: 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.
|
Combination (Melatonin+Bedtime Bank)
n=13 participants at risk
Participants in this arm will take 3 mg melatonin 30 minutes before bedtime and utilize the Bedtime Bank, a behavioral sleep intervention.
Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
Bedtime Bank: 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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild Dermatitis
|
11.1%
3/27 • Number of events 3 • 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).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
|
3.8%
1/26 • Number of events 2 • 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).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
|
0.00%
0/13 • 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).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • 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).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
|
3.8%
1/26 • 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).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
|
0.00%
0/13 • 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).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place