NCT02962037

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

October 30, 2016

Last Update Submit

November 9, 2016

Conditions

Delayed Sleep Phase Syndrome

Outcome Measures

Primary Outcomes (6)

  • Sleep patterns

    Sleep actigraph

    1 week

  • Melatonin secretion

    Melatonin -Sulfate Urine

    12 hours

  • Brief Symptom Inventory

    BSI Questionnaire- assess the subject's emotional state

    1 day

  • Epworth Sleepiness Scale

    ESS Questionnaire- measure daytime sleepiness

    1 day

  • Karolinska Sleepiness Scale

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

    1 day

  • Continuous Performance Test 3

    Task-oriented computerized assessment of attention-related problems

    1 day

Study Arms (2)

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

Other: Melatonin and light therapy

Interventions

Melatonin and light therapyOTHER
After treatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with DSPS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

MelatoninPhototherapy

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 30, 2016

First Posted

November 11, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share