Delayed Sleep Phase Syndrome
Conditions
Brief summary
This study will test whether measuring the circadian clock during treatment of delayed sleep-wake phase disorder results in greater improvements in sleep compared to estimating the circadian clock.
Detailed description
The study is a randomized, controlled, parallel double-blind 4-week trial of 0.5 mgs of exogenous melatonin timed to either 3 h before actual dim light melatonin onset (DLMO) based on in-home measurement (M-DLMO, n = 25) or 3 h before DLMO estimated at 2 h before average sleep onset time based on actigraphy and sleep diary (E-DLMO, n = 25) in adult participants with delayed sleep-wake phase disorder. All participants will receive melatonin 0.5 mgs. Outcomes include change in DLMO, subjective and objective sleep parameters, and daytime symptoms. As of January 7, 2020, the Insomnia Severity Index was removed from the IRB-approved protocol. No data were collected for this measure.
Interventions
DRUGMelatonin 0.5 MG
Melatonin tablet
OTHERDim Light Melatonin Onset (salivary)
Test to determine the time of melatonin onset in saliva under dim light conditions
Sponsors
American Academy of Sleep Medicine
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet diagnostic criteria for delayed sleep wake phase disorder * Female participants of childbearing potential must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.
Exclusion criteria
* Hypersensitivity to melatonin or any other component of the product * Sleep disorder other than delayed sleep wake phase disorder * Medical and psychiatric conditions that may influence sleep or be affected by melatonin * Current use of medications which may have interactions with melatonin * Pregnancy or breastfeeding * Routine night shift work * Past month travel or planned travel during the study across more than one time zone * Use of melatonin in the past month * Current use of medications that may interfere with the measurement of melatonin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks | After 4 weeks of melatonin therapy | Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks | After 4 weeks of melatonin therapy | Sleep onset time is measured in clock time and reflects time of falling asleep. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later fall asleep time and negative scores indicate a shift towards an earlier fall asleep time. |
| Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks | After 4 weeks of melatonin therapy | Sleep offset time is measured in clock time and reflects time of waking for the day. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later wake time and negative scores indicate a shift towards an earlier wake time. |
| Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks | After 4 weeks of melatonin therapy | Length of time to sleep onset latency in minutes (reflects time to fall asleep). The change score is calculated as time at 4 weeks minus baseline time. Thus, a negative scores indicate a reduction in time to fall asleep, whereas positive scores indicate an increase in time to fall asleep. |
| Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of daytime sleepiness. Scores range from 0 to 24. Scores of 10 or higher indicate excessive daytime sleepiness. The change score is calculated as score at 4 weeks minus baseline score.Thus, positive scores indicate an increase in sleepiness, whereas negative scores indicate a reduction in sleepiness. |
| Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of daytime fatigue. Scores range from 20-100; higher scores indicate more fatigue. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in fatigue, whereas negative scores indicate a reduction in fatigue. |
| Change From Baseline Score on Sheehan Disability Scale at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of functional impairment in works/school, social, and family life. Scores range from 0-30; higher scores indicate more impairment. The change score is calculated as time at 4 weeks minus baseline time Thus, positive scores indicate increased impairment, whereas negative scores indicate a reduction in impairment. |
| Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks | After 4 weeks of melatonin therapy | Change in total sleep time is measured in hours. The change score is calculated by subtracting total sleep time at 4 weeks from total sleep time at baseline. Thus, positive scores indicate an increase in total sleep time, whereas negative scores indicate a decrease in total sleep time. |
| Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of generalized anxiety symptoms. Scores range from 0-21; higher scores indicate more severe anxiety. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in anxiety, whereas negative scores indicate a reduction in anxiety. |
| Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of sleep quality. Seven subscale scores are summed to obtain a global score. Global scores range from 0 to 21; scores of 5 or higher indicate poor sleep quality. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate a worsening of sleep quality, whereas negative scores indicate an improvement in sleep quality. |
| Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of chronotype. Scores range from 16-86. Lower scores indicate more eveningness.The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate a shift towards more morningness, whereas negative scores indicate a shift towards more eveningness. |
| Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of sleep disturbances. Scores range from 8-40. Higher scores indicate greater sleep disturbance. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate a worsening of sleep disturbance, whereas negative scores indicate an improvement in sleep disturbance. |
| Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of impairment related to sleep. Scores range from 8-40. Higher scores indicate greater impairment due to sleep. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in impairment due to sleep, whereas negative scores indicate a reduction in impairment due to sleep. |
| Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks | After 4 weeks of melatonin therapy | Self-report of depression symptoms. Scores range from 0-27; higher scores indicate more severe depression. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in depression, whereas negative scores indicate a reduction in depression. |
Countries
United States
Participant flow
Pre-assignment details
44 participants total were enrolled in this trial, 4 of whom withdrew before randomization to the arms.
Participants by arm
| Arm | Count |
|---|---|
| Measured DLMO Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before measured dim light melatonin onset.
Melatonin 0.5 MG: Melatonin tablet
Dim Light Melatonin Onset (salivary): Test to determine the time of melatonin onset in saliva under dim light conditions | 20 |
| Estimated DLMO Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before estimated dim light melatonin onset.
Melatonin 0.5 MG: Melatonin tablet | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Measured DLMO | Estimated DLMO | Total |
|---|---|---|---|
| Age, Continuous | 25.45 years STANDARD_DEVIATION 6.19 | 26.70 years STANDARD_DEVIATION 5.62 | 26.08 years STANDARD_DEVIATION 5.87 |
| Dim Light Melatonin Onset | 22.90 Clock time in hours STANDARD_DEVIATION 2.23 | 22.55 Clock time in hours STANDARD_DEVIATION 1.52 | 22.75 Clock time in hours STANDARD_DEVIATION 1.93 |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black/African American | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized I have two or more racial backgrounds | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 19 Participants | 19 Participants | 38 Participants |
| Race/Ethnicity, Customized White/Caucasian | 11 Participants | 18 Participants | 29 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 16 / 20 | 16 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.
Time frame: After 4 weeks of melatonin therapy
Population: Data were not analyzed for 2 participants in the Measured DLMO group and 7 participants in the Estimated DLMO group due to missing or incalculable DLMO data at one or both of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks | -1.23 Hours | Standard Deviation 1.53 |
| Estimated DLMO | Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks | -1.58 Hours | Standard Deviation 1.3 |
p-value: 0.51t-test, 2 sided
Secondary
Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
Self-report of daytime sleepiness. Scores range from 0 to 24. Scores of 10 or higher indicate excessive daytime sleepiness. The change score is calculated as score at 4 weeks minus baseline score.Thus, positive scores indicate an increase in sleepiness, whereas negative scores indicate a reduction in sleepiness.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks | -1.61 score on a scale | Standard Deviation 2.75 |
| Estimated DLMO | Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks | -0.78 score on a scale | Standard Deviation 3.8 |
p-value: 0.456t-test, 2 sided
Secondary
Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks
Self-report of generalized anxiety symptoms. Scores range from 0-21; higher scores indicate more severe anxiety. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in anxiety, whereas negative scores indicate a reduction in anxiety.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks | 1.11 units on a scale | Standard Deviation 3.03 |
| Estimated DLMO | Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks | -0.50 units on a scale | Standard Deviation 2.79 |
p-value: 0.106t-test, 2 sided
Secondary
Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks
Self-report of daytime fatigue. Scores range from 20-100; higher scores indicate more fatigue. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in fatigue, whereas negative scores indicate a reduction in fatigue.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks | -3.78 score on a scale | Standard Deviation 8.73 |
| Estimated DLMO | Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks | -6.50 score on a scale | Standard Deviation 10.43 |
p-value: 0.402t-test, 2 sided
Secondary
Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks
Self-report of depression symptoms. Scores range from 0-27; higher scores indicate more severe depression. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in depression, whereas negative scores indicate a reduction in depression.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks | 0.28 Score on a Questionnaire | Standard Deviation 2.63 |
| Estimated DLMO | Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks | -0.39 Score on a Questionnaire | Standard Deviation 3.53 |
p-value: 0.525t-test, 2 sided
Secondary
Change From Baseline Score on Sheehan Disability Scale at 4 Weeks
Self-report of functional impairment in works/school, social, and family life. Scores range from 0-30; higher scores indicate more impairment. The change score is calculated as time at 4 weeks minus baseline time Thus, positive scores indicate increased impairment, whereas negative scores indicate a reduction in impairment.
Time frame: After 4 weeks of melatonin therapy
Population: 10 participants in the Measured DLMO and 5 participants in the Estimated DLMO group did not complete this measure due to an error in data collection procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Sheehan Disability Scale at 4 Weeks | -0.33 score on a scale | Standard Deviation 4.92 |
| Estimated DLMO | Change From Baseline Score on Sheehan Disability Scale at 4 Weeks | -5.85 score on a scale | Standard Deviation 6.63 |
p-value: 0.047t-test, 2 sided
Secondary
Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks
Self-report of chronotype. Scores range from 16-86. Lower scores indicate more eveningness.The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate a shift towards more morningness, whereas negative scores indicate a shift towards more eveningness.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks | 4.89 score on a scale | Standard Deviation 4.73 |
| Estimated DLMO | Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks | 12.17 score on a scale | Standard Deviation 9.65 |
p-value: 0.007t-test, 2 sided
Secondary
Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks
Self-report of sleep quality. Seven subscale scores are summed to obtain a global score. Global scores range from 0 to 21; scores of 5 or higher indicate poor sleep quality. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate a worsening of sleep quality, whereas negative scores indicate an improvement in sleep quality.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO and one participant in the Estimated DLMO group were not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks | 1.61 score on a scale | Standard Deviation 2.87 |
| Estimated DLMO | Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks | -0.59 score on a scale | Standard Deviation 3.74 |
p-value: 0.059t-test, 2 sided
Secondary
Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks
Self-report of sleep disturbances. Scores range from 8-40. Higher scores indicate greater sleep disturbance. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate a worsening of sleep disturbance, whereas negative scores indicate an improvement in sleep disturbance.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks | -3.56 score on a scale | Standard Deviation 6.28 |
| Estimated DLMO | Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks | -5.94 score on a scale | Standard Deviation 5.85 |
p-value: 0.246t-test, 2 sided
Secondary
Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks
Self-report of impairment related to sleep. Scores range from 8-40. Higher scores indicate greater impairment due to sleep. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in impairment due to sleep, whereas negative scores indicate a reduction in impairment due to sleep.
Time frame: After 4 weeks of melatonin therapy
Population: One participant in the Measured DLMO group was not included in the analysis because they did not complete the measure at one of the time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Measured DLMO | Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks | -3.94 score on a scale | Standard Deviation 5.25 |
| Estimated DLMO | Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks | -6.11 score on a scale | Standard Deviation 7.75 |
p-value: 0.333t-test, 2 sided
Secondary
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks
Sleep offset time is measured in clock time and reflects time of waking for the day. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later wake time and negative scores indicate a shift towards an earlier wake time.
Time frame: After 4 weeks of melatonin therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks | change in sleep offset time per diary | -1.61 Hours | Standard Deviation 0.98 |
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks | change in sleep offset time per actigraphy | -1.15 Hours | Standard Deviation 0.89 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks | change in sleep offset time per diary | -1.96 Hours | Standard Deviation 0.96 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks | change in sleep offset time per actigraphy | -1.45 Hours | Standard Deviation 1.18 |
Comparison: Per diaryp-value: 0.27t-test, 2 sided
Comparison: Per wrist actigraphyp-value: 0.406t-test, 2 sided
Secondary
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks
Sleep onset time is measured in clock time and reflects time of falling asleep. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later fall asleep time and negative scores indicate a shift towards an earlier fall asleep time.
Time frame: After 4 weeks of melatonin therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks | change in sleep onset time per diary | -1.73 Hours | Standard Deviation 1.1 |
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks | change in sleep onset time per actigraphy | -1.58 Hours | Standard Deviation 1.11 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks | change in sleep onset time per diary | -1.84 Hours | Standard Deviation 1.4 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks | change in sleep onset time per actigraphy | -1.63 Hours | Standard Deviation 1.47 |
Comparison: Per diaryp-value: 0.787t-test, 2 sided
Comparison: Per wrist actigraphyp-value: 0.916t-test, 2 sided
Secondary
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
Change in total sleep time is measured in hours. The change score is calculated by subtracting total sleep time at 4 weeks from total sleep time at baseline. Thus, positive scores indicate an increase in total sleep time, whereas negative scores indicate a decrease in total sleep time.
Time frame: After 4 weeks of melatonin therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks | change in total sleep time per diary | 0.41 Hours | Standard Deviation 0.79 |
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks | change in total sleep time per actigraphy | 0.63 Hours | Standard Deviation 0.79 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks | change in total sleep time per diary | 0.65 Hours | Standard Deviation 0.99 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks | change in total sleep time per actigraphy | 0.66 Hours | Standard Deviation 1 |
Comparison: Per diaryp-value: 0.411t-test, 2 sided
Comparison: Per wrist actigraphyp-value: 0.92t-test, 2 sided
Secondary
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
Length of time to sleep onset latency in minutes (reflects time to fall asleep). The change score is calculated as time at 4 weeks minus baseline time. Thus, a negative scores indicate a reduction in time to fall asleep, whereas positive scores indicate an increase in time to fall asleep.
Time frame: After 4 weeks of melatonin therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks | change in sleep onset latency per diary | -14.35 Minutes | Standard Deviation 32.61 |
| Measured DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks | change in sleep onset latency per actigraphy | -9.75 Minutes | Standard Deviation 36.83 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks | change in sleep onset latency per diary | -10.21 Minutes | Standard Deviation 17.25 |
| Estimated DLMO | Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks | change in sleep onset latency per actigraphy | -0.53 Minutes | Standard Deviation 25.19 |
Comparison: Per diaryp-value: 0.635t-test, 2 sided
Comparison: Per wrist actigraphyp-value: 0.383t-test, 2 sided