Back to resultsAre Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder?
Primary Purpose
Delayed Sleep Phase Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Melatonin and light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Delayed Sleep Phase Syndrome
Eligibility Criteria
Inclusion Criteria:
- diagnosed with DSPS
Exclusion Criteria:
- attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Base line
After treatment
Arm Description
the subject will take the tests in the morning and the evening
the subject will take the tests in the morning and the evening
Outcomes
Primary Outcome Measures
Sleep patterns
Sleep actigraph
Melatonin secretion
Melatonin -Sulfate Urine
Brief Symptom Inventory
BSI Questionnaire- assess the subject's emotional state
Epworth Sleepiness Scale
ESS Questionnaire- measure daytime sleepiness
Karolinska Sleepiness Scale
KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness
Continuous Performance Test 3
Task-oriented computerized assessment of attention-related problems
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02962037
Brief Title
Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder?
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?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lilach Kemer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Sleep Phase Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Base line
Arm Type
No Intervention
Arm Description
the subject will take the tests in the morning and the evening
Arm Title
After treatment
Arm Type
Experimental
Arm Description
the subject will take the tests in the morning and the evening
Intervention Type
Other
Intervention Name(s)
Melatonin and light therapy
Primary Outcome Measure Information:
Title
Sleep patterns
Description
Sleep actigraph
Time Frame
1 week
Title
Melatonin secretion
Description
Melatonin -Sulfate Urine
Time Frame
12 hours
Title
Brief Symptom Inventory
Description
BSI Questionnaire- assess the subject's emotional state
Time Frame
1 day
Title
Epworth Sleepiness Scale
Description
ESS Questionnaire- measure daytime sleepiness
Time Frame
1 day
Title
Karolinska Sleepiness Scale
Description
KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness
Time Frame
1 day
Title
Continuous Performance Test 3
Description
Task-oriented computerized assessment of attention-related problems
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosed with DSPS
Exclusion Criteria:
attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder?
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