ClinicalTrials.gg
Status unknownNCT02962037Updated Nov 11, 2016

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

A Phase 4 interventional study of Melatonin and light therapy in Delayed Sleep Phase Syndrome, sponsored by Lilach Kemer. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-11.

Sponsored by Lilach Kemer · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Delayed Sleep Phase Syndrome
03

In context

Sleep Disorders, Circadian Rhythm

139 studies on the registry are indexed under Sleep Disorders, Circadian Rhythm; 24 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 105 interventional studies indexed under Sleep Disorders, Circadian Rhythm.

Browse Sleep Disorders, Circadian Rhythm studies →

Lead sponsor

This is the only study on the registry with Lilach Kemer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosed with DSPS

Exclusion criteria

Exclusion Criteria:

  • attention deficit hyperactivity disorder - diagnosed, affective disorder- diagnosed
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • OtherMelatonin and light therapy
06

What researchers measure

Primary outcomes

  1. Sleep patterns

    Sleep actigraph

    Time frame: 1 week

  2. Melatonin secretion

    Melatonin -Sulfate Urine

    Time frame: 12 hours

  3. Brief Symptom Inventory

    BSI Questionnaire- assess the subject's emotional state

    Time frame: 1 day

  4. Epworth Sleepiness Scale

    ESS Questionnaire- measure daytime sleepiness

    Time frame: 1 day

  5. Karolinska Sleepiness Scale

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

    Time frame: 1 day

  6. Continuous Performance Test 3

    Task-oriented computerized assessment of attention-related problems

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02962037
Lead sponsor
Lilach Kemer
Responsible party
Lilach Kemer (Dr., Assuta Medical Center) — Sponsor-investigator
First posted
Nov 11, 2016
Start date
Nov 2016
Primary completion
Aug 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
Nov 11, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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