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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estimated DLMO | Active Comparator | 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. |
|
| Measured DLMO | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 0.5 MG | Drug | Melatonin tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 4 weeks of melatonin therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Swanson, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38445651 | Derived | Swanson LM, de Sibour T, DuBuc K, Conroy DA, Raglan GB, Lorang K, Zollars J, Hershner S, Arnedt JT, Burgess HJ. Low-dose exogenous melatonin plus evening dim light and time in bed scheduling advances circadian phase irrespective of measured or estimated dim light melatonin onset time: preliminary findings. J Clin Sleep Med. 2024 Jul 1;20(7):1131-1140. doi: 10.5664/jcsm.11076. |
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44 participants total were enrolled in this trial, 4 of whom withdrew before randomization to the arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Hours | After 4 weeks of melatonin therapy |
|
4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Swanson | University of Michigan | 734-764-2242 | lmswan@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2022 | Oct 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Dim Light Melatonin Onset (salivary) |
| Other |
Test to determine the time of melatonin onset in saliva under dim light conditions |
|
| After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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. | After 4 weeks of melatonin therapy |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dim Light Melatonin Onset | Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time. | Baseline DLMO was not calculable for 5 participants in the E-DLMO group | Mean | Standard Deviation | Clock time in hours |
|
| OG001 | 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 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Hours | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Hours | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Hours | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Minutes | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a Questionnaire | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | After 4 weeks of melatonin therapy |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 16 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 16 | 20 |
| Eye irritation | Eye disorders | MedDRA (25.0) | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Decreased appetite | General disorders | MedDRA (25.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
|
| Headaches | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| 0.920 |
| Superiority |
| 0.916 |
| Superiority |
| 0.406 |
| Superiority |
| 0.383 |
| Superiority |