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

Sponsor
Lilach Kemer (Other)
Overall Status
Unknown status
CT.gov ID
NCT02962037
Collaborator
(none)
20
Enrollment
2
Arms
12
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Nov 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sleep patterns [1 week]

    Sleep actigraph

  2. Melatonin secretion [12 hours]

    Melatonin -Sulfate Urine

  3. Brief Symptom Inventory [1 day]

    BSI Questionnaire- assess the subject's emotional state

  4. Epworth Sleepiness Scale [1 day]

    ESS Questionnaire- measure daytime sleepiness

  5. Karolinska Sleepiness Scale [1 day]

    KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness

  6. Continuous Performance Test 3 [1 day]

    Task-oriented computerized assessment of attention-related problems

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • diagnosed with DSPS
Exclusion Criteria:
  • attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lilach Kemer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lilach Kemer, Dr., Assuta Medical Center
ClinicalTrials.gov Identifier:
NCT02962037
Other Study ID Numbers:
  • 0092-16-ASMC
First Posted:
Nov 11, 2016
Last Update Posted:
Nov 11, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Melatonin

Study Results

No Results Posted as of Nov 11, 2016