Delayed Sleep Phase SyndromePhase 4NCT02962037
Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder?
A Phase 4 study testing Melatonin and light therapy in people with Delayed Sleep Phase Syndrome, run by Lilach Kemer.
Trial summary
The purpose of this study is to determine whether the known treatment for DSPS also improve the cognitive ability and mood of the patients. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Sleep Phase Syndrome
- What is being tested?
- Melatonin and light therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosed with DSPS
Who cannot join
- attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed
About this study
Official title: Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities (Attention and Concentration, Mood and Fatigue) Before Handling the Disorder? And Whether the Treatment Fixes the Disorder?
The purpose of this study is to determine whether the known treatment for DSPS also improve the cognitive ability and mood of the patients.
Read the detailed description
Every participant will take a few test and tasks that are going to test his cognitive ability and mood before treatment in 08:00 and 20:00, and again the same tests at the same hours after the treatment.
- Conditions
- Delayed Sleep Phase Syndrome
- Being tested
- Melatonin and light therapy
- 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 and light therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Base line | No intervention | the subject will take the tests in the morning and the evening |
| After treatment | Experimental | the subject will take the tests in the morning and the evening Receives: Other: Melatonin and light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep patterns
Sleep actigraph
Measured: 1 week
Melatonin secretion
Melatonin -Sulfate Urine
Measured: 12 hours
Brief Symptom Inventory
BSI Questionnaire- assess the subject's emotional state
Measured: 1 day
Epworth Sleepiness Scale
ESS Questionnaire- measure daytime sleepiness
Measured: 1 day
Karolinska Sleepiness Scale
KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness
Measured: 1 day
Continuous Performance Test 3
Task-oriented computerized assessment of attention-related problems
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Sleep Phase SyndromeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lilach Kemer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lilach Kemer, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962037
- Sponsor's protocol ID
- 0092-16-ASMC
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities (Attention and Concentration, Mood and Fatigue) Before Handling the Disorder? And Whether the Treatment Fixes the Disorder?
- ClinicalTrials.gov ID
- NCT02962037
- Acronym / sponsor ID
- 0092-16-ASMC
- Conditions
- Delayed Sleep Phase Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lilach KemerUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the known treatment for DSPS also improve the cognitive ability and mood of the patients.
Detailed description
Every participant will take a few test and tasks that are going to test his cognitive ability and mood before treatment in 08:00 and 20:00, and again the same tests at the same hours after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Base line | No intervention | –the subject will take the tests in the morning and the evening |
| After treatment | Experimental | Other: Melatonin and light therapythe subject will take the tests in the morning and the evening |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosed with DSPS
Key exclusion criteria (1 listed)
- attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed
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 and light therapy | Other | After treatment |
Primary outcome
Sleep patterns
Time frame: 1 week
Sleep actigraph
Melatonin secretion
Time frame: 12 hours
Melatonin -Sulfate Urine
Brief Symptom Inventory
Time frame: 1 day
BSI Questionnaire- assess the subject's emotional state
Epworth Sleepiness Scale
Time frame: 1 day
ESS Questionnaire- measure daytime sleepiness
Karolinska Sleepiness Scale
Time frame: 1 day
KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness
Continuous Performance Test 3
Time frame: 1 day
Task-oriented computerized assessment of attention-related problems
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin and light therapy in people with Delayed Sleep Phase Syndrome, run by Lilach Kemer.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Sleep patterns (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2016.