Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Are Patients Suffering From DSPS Show Compromising in Everyday Functions and Abilities Before Handling the Disorder?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02962037
Recruitment Status : Unknown
Verified November 2016 by Lilach Kemer, Assuta Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Lilach Kemer, Assuta Medical Center

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.

Condition or disease Intervention/treatment Phase
Delayed Sleep Phase Syndrome Other: Melatonin and light therapy Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
No Intervention: Base line
the subject will take the tests in the morning and the evening
Experimental: After treatment
the subject will take the tests in the morning and the evening
Other: Melatonin and light therapy



Primary Outcome Measures :
  1. Sleep patterns [ Time Frame: 1 week ]
    Sleep actigraph

  2. Melatonin secretion [ Time Frame: 12 hours ]
    Melatonin -Sulfate Urine

  3. Brief Symptom Inventory [ Time Frame: 1 day ]
    BSI Questionnaire- assess the subject's emotional state

  4. Epworth Sleepiness Scale [ Time Frame: 1 day ]
    ESS Questionnaire- measure daytime sleepiness

  5. Karolinska Sleepiness Scale [ Time Frame: 1 day ]
    KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness

  6. Continuous Performance Test 3 [ Time Frame: 1 day ]
    Task-oriented computerized assessment of attention-related problems



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosed with DSPS

Exclusion Criteria:

  • attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed

Layout table for additonal information
Responsible Party: Lilach Kemer, Dr., Assuta Medical Center
ClinicalTrials.gov Identifier: NCT02962037    
Other Study ID Numbers: 0092-16-ASMC
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Nervous System Diseases
Dyssomnias
Sleep Wake Disorders
Occupational Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants