Cancer Malignancies
Conditions
Keywords
Melatonin, Neurocognitive impairment, Sleep disturbance, Childhood cancer survivors
Brief summary
Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors. 2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors. This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.
Detailed description
All participants undergo a general neurocognitive evaluation at baseline and 6-month follow-up, focused on assessment of intelligence, academic skills, attention, processing speed, memory and executive functions. Sleep parameters using self-report and actigraphy will be assessed at three time points during the study: Baseline, 3-months, and 6-months. Participants will be divided into 3 mutually exclusive groups: * Cohort 1: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes less than once a week during the past month. * Cohort 2: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes at least once a week during the past month. * Cohort 3: Participant is absent of neurocognitive impairment defined as performance \>10th percentile on all six measures of attention, memory, and executive functioning, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes \> once a week during the past month. Within each group, participants will be randomly assigned to take either 3 mgs of time release melatonin or placebo 1-2 hours before bedtime each night for 6 months. Psychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment. Biological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation.
Interventions
DRUGmelatonin
Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
DRUGplacebo
Placebo tablets to match the melatonin will be comprised of inert substances.
Sponsors
National Cancer Institute (NCI)
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital * 10 or more years from diagnosis * 18 years of age or older * Able to speak and understand the English language * Participant has a full scale intelligence quotient (FSIQ) score \>79. * Cohort 1 participant: * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile. * Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes \< once a week during the past month. * Cohort 2 participant: * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile. * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month. * Cohort 3 participant: * Is absent of neurocognitive impairment defined as performance \>10th percentile on all six measures of attention, memory, and executive functioning. * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month. * Female participant of childbearing age must not be pregnant or lactating * Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods
Exclusion criteria
* Known allergy to melatonin or any ingredients of the study product or placebo * Participant currently is taking melatonin * Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome) * Known diabetes mellitus - insulin treated * Participant has uncontrolled seizure disorder in past 12 months * Reported current illicit drug or alcohol abuse or dependence * Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder) * Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R)) * Employed in a position that requires night work (i.e. 10pm to 6am) * Females who are pregnant or lactating/nursing * History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment * Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Baseline and 6 months after start of therapy | Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency as Measured by Actigraphy and Self-report. | Baseline and six months after start of therapy | Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups. |
| Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Baseline and six months after start of therapy | Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved. |
Countries
United States
Participant flow
Recruitment details
911 participants were enrolled and screened between February 2013 and June 2017. Of the 911, 298 were ineligible and 33 withdrew prior to randomization. 580 were randomized.
Pre-assignment details
The remaining 580 participants were categorized into three mutually exclusive groups: (1) neurocognitive impairment (NI) without delayed sleep onset latency (DSOL), (2) NI with DSOL, and (3) No NI with DSOL. Participants were then randomized to take melatonin or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Melatonin: NI Without DSOL Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night. | 58 |
| Placebo: NI Without DSOL Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances. | 58 |
| Melatonin: NI With DSOL Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night. | 62 |
| Placebo: NI With DSOL Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances. | 68 |
| Melatonin: No NI With DSOL Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night. | 66 |
| Placebo: No NI With DSOL Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances. | 68 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 2 | 0 | 2 |
| Overall Study | Ineligible | 2 | 1 | 2 | 0 | 0 | 1 |
| Overall Study | Noncompliant | 9 | 9 | 17 | 18 | 15 | 9 |
| Overall Study | Side effects | 1 | 4 | 8 | 4 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 15 | 9 | 12 | 11 | 8 | 12 |
Baseline characteristics
| Characteristic | Melatonin: NI Without DSOL | Placebo: NI Without DSOL | Melatonin: NI With DSOL | Placebo: NI With DSOL | Melatonin: No NI With DSOL | Placebo: No NI With DSOL | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.8 years STANDARD_DEVIATION 9.1 | 36.4 years STANDARD_DEVIATION 8.1 | 32.8 years STANDARD_DEVIATION 7.8 | 32.4 years STANDARD_DEVIATION 9.3 | 35.8 years STANDARD_DEVIATION 9 | 36.5 years STANDARD_DEVIATION 8.2 | 34.46 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 52 Participants | 59 Participants | 61 Participants | 59 Participants | 61 Participants | 347 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 1 Participants | 3 Participants | 6 Participants | 7 Participants | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 8 Participants | 9 Participants | 1 Participants | 7 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 52 Participants | 53 Participants | 53 Participants | 59 Participants | 62 Participants | 59 Participants | 338 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 37 Participants | 39 Participants | 35 Participants | 46 Participants | 207 Participants |
| Sex: Female, Male Male | 32 Participants | 34 Participants | 25 Participants | 29 Participants | 31 Participants | 22 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 | 0 / 62 | 0 / 68 | 0 / 66 | 0 / 68 |
| other Total, other adverse events | 37 / 58 | 37 / 58 | 52 / 62 | 60 / 68 | 57 / 66 | 58 / 68 |
| serious Total, serious adverse events | 2 / 58 | 2 / 58 | 9 / 62 | 6 / 68 | 2 / 66 | 10 / 68 |
Outcome results
Primary
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
Time frame: Baseline and 6 months after start of therapy
Population: Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Sustained Attention Difference | 0.06 Z-score | Standard Deviation 1.11 |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Working Memory Difference | 0.17 Z-score | Standard Deviation 0.67 |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Long-term Verbal Memory Difference | 0.02 Z-score | Standard Deviation 1.16 |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Flexibility | 0.31 Z-score | Standard Deviation 1.22 |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Fluency Difference | 0.14 Z-score | Standard Deviation 0.68 |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Auditory Attention Difference | 0.35 Z-score | Standard Deviation 1.02 |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Auditory Attention Difference | 0.18 Z-score | Standard Deviation 0.87 |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Sustained Attention Difference | 0.16 Z-score | Standard Deviation 1.3 |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Fluency Difference | 0.21 Z-score | Standard Deviation 0.74 |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Long-term Verbal Memory Difference | -0.03 Z-score | Standard Deviation 1.04 |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Flexibility | 0.31 Z-score | Standard Deviation 1.06 |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Working Memory Difference | 0.07 Z-score | Standard Deviation 0.82 |
| Melatonin: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Sustained Attention Difference | 0.24 Z-score | Standard Deviation 1.16 |
| Melatonin: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Working Memory Difference | 0.03 Z-score | Standard Deviation 0.75 |
| Melatonin: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Flexibility | 0.31 Z-score | Standard Deviation 1.37 |
| Melatonin: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Auditory Attention Difference | 0.06 Z-score | Standard Deviation 1.11 |
| Melatonin: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Long-term Verbal Memory Difference | -0.13 Z-score | Standard Deviation 0.98 |
| Melatonin: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Fluency Difference | 0.16 Z-score | Standard Deviation 0.64 |
| Placebo: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Fluency Difference | 0.18 Z-score | Standard Deviation 0.63 |
| Placebo: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Long-term Verbal Memory Difference | -0.15 Z-score | Standard Deviation 1.29 |
| Placebo: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Cognitive Flexibility | 0.18 Z-score | Standard Deviation 1.19 |
| Placebo: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Sustained Attention Difference | 0.08 Z-score | Standard Deviation 1.39 |
| Placebo: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Working Memory Difference | 0.004 Z-score | Standard Deviation 0.76 |
| Placebo: NI With DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | Auditory Attention Difference | 0.37 Z-score | Standard Deviation 0.96 |
Secondary
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.
Time frame: Baseline and six months after start of therapy
Population: Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Working Memory Difference | 0.04 Z-score |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Auditory Attention Difference | 0.22 Z-score |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Long-term Verbal Memory Difference | 0.07 Z-score |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Cognitive Flexibility | 0.30 Z-score |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Cognitive Fluency Difference | -0.22 Z-score |
| Melatonin: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sustained Attention Difference | -0.10 Z-score |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Cognitive Fluency Difference | 0.03 Z-score |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sustained Attention Difference | -0.16 Z-score |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Long-term Verbal Memory Difference | -0.02 Z-score |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Cognitive Flexibility | 0.15 Z-score |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Working Memory Difference | -0.001 Z-score |
| Placebo: NI Without DSOL | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report. | Auditory Attention Difference | -0.09 Z-score |
Secondary
Sleep Onset Latency as Measured by Actigraphy and Self-report.
Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.
Time frame: Baseline and six months after start of therapy
Population: Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Melatonin: NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleep onset latency - actigraphy | 5.66 minutes | Standard Deviation 29.7 |
| Melatonin: NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleet onset latency - self-report | -20.59 minutes | Standard Deviation 23.73 |
| Placebo: NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleet onset latency - self-report | 17.79 minutes | Standard Deviation 37.19 |
| Placebo: NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleep onset latency - actigraphy | -10.96 minutes | Standard Deviation 30.21 |
| Melatonin: No NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleet onset latency - self-report | -18.14 minutes | Standard Deviation 27.06 |
| Melatonin: No NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleep onset latency - actigraphy | -8.47 minutes | Standard Deviation 23.95 |
| Placebo: No NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleet onset latency - self-report | -29.03 minutes | Standard Deviation 64.49 |
| Placebo: No NI With DSOL | Sleep Onset Latency as Measured by Actigraphy and Self-report. | Sleep onset latency - actigraphy | 1.95 minutes | Standard Deviation 39.71 |