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

Delayed Sleep Phase Syndrome Clinical Trial

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02962037
• Other study ID #: 0092-16-ASMC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 30, 2016
• Last updated: November 9, 2016
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Assuta Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• diagnosed with DSPS

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delayed Sleep Phase Syndrome
• Sleep Disorders, Circadian Rhythm

Intervention

Other:
• Melatonin and light therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lilach Kemer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep patterns	Sleep actigraph	1 week	No
Primary	Melatonin secretion	Melatonin -Sulfate Urine	12 hours	No
Primary	Brief Symptom Inventory	BSI Questionnaire- assess the subject's emotional state	1 day	No
Primary	Epworth Sleepiness Scale	ESS Questionnaire- measure daytime sleepiness	1 day	No
Primary	Karolinska Sleepiness Scale	KSS Questionnaire- self-reported, subjective assessment of the subject's level of drowsiness	1 day	No
Primary	Continuous Performance Test 3	Task-oriented computerized assessment of attention-related problems	1 day	No