Delayed Sleep Phase SyndromePhase 3NCT03715465
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
A Phase 3 study testing Melatonin 0.5 MG and Dim Light Melatonin Onset (salivary) in people with Delayed Sleep Phase Syndrome, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Delayed Sleep Phase Syndrome
- What is being tested?
- Melatonin 0.5 MG and Dim Light Melatonin Onset (salivary)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to 5 Nov 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
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.
Read the 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.
- Conditions
- Delayed Sleep Phase Syndrome
- Being tested
- Melatonin 0.5 MG, Dim Light Melatonin Onset (salivary)
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 0.5 MGDrug
Melatonin tablet
Dim Light Melatonin Onset (salivary)Other
Test to determine the time of melatonin onset in saliva under dim light conditions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Melatonin 0.5 MG |
| 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. Receives: Drug: Melatonin 0.5 MG; Other: Dim Light Melatonin Onset (salivary) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 4 weeks of melatonin therapy
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 4 weeks of melatonin therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start15 Feb 2019
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Sleep Phase SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Leslie Swanson, University of Michigan
- Investigators
- Leslie Swanson, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715465
- Sponsor's protocol ID
- HUM00145052
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2018
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38445651
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03715465
- Acronym / sponsor ID
- HUM00145052
- Conditions
- Delayed Sleep Phase Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 25 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estimated DLMO | Active comparator | Drug: Melatonin 0.5 MGFour 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 | Drug: Melatonin 0.5 MG, Other: Dim Light Melatonin Onset (salivary)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 0.5 MGMelatonin tablet | Drug | Estimated DLMO, Measured DLMO |
| Dim Light Melatonin Onset (salivary)Test to determine the time of melatonin onset in saliva under dim light conditions | Other | Measured DLMO |
Primary outcome
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
Time frame: 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.
13 secondary outcomes
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
Time frame: 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
Time frame: 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
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on Sheehan Disability Scale at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks
Time frame: After 4 weeks of melatonin therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38445651Swanson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Swanson, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 0.5 MG and Dim Light Melatonin Onset (salivary) in people with Delayed Sleep Phase Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks (time frame: After 4 weeks of melatonin therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.