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Phototherapy

Phototherapy for Shift Work Sleep Disorder (SHIFT Trial)

N/A

Recruiting

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within two days of treatment for a duration of 24 hours

Awards & highlights

SHIFT Trial Summary

This trial will compare the effects of two different light exposure schedules on Shift Work Disorder.

Who is the study for?

This trial is for night shift workers who've been on this schedule for at least 6 months and have Shift Work Disorder based on ICSD-3 criteria. They must work a minimum of two night shifts per week, starting between 6 PM and 2 AM, lasting from 8 to 12 hours. Pregnant individuals, those with other sleep disorders or unstable major medical conditions, heavy tobacco users, and people using certain drugs are excluded.Check my eligibility

What is being tested?

The study is testing the effectiveness of personalized light exposure schedules versus non-personalized ones in treating Shift Work Disorder among night shift workers. It aims to determine if tailoring light exposure can improve sleep quality and overall well-being.See study design

What are the potential side effects?

While phototherapy is generally considered safe, potential side effects may include eyestrain, headache, nausea or agitation during initial use. Long-term side effects are rare but could involve disruption of sleep patterns or mood changes.

SHIFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Shift Work Disorder.

SHIFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within two days of treatment for a duration of 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within two days of treatment for a duration of 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and within two days of treatment for a duration of 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dim light melatonin onset

Secondary outcome measures

Daytime sleepiness

Insomnia

Side effects data

From 2016 Phase 2 trial • 91 Patients • NCT01887327

17%

Cardiac murmur

17%

Erythema

13%

Umbilical hernia

10%

Rash

10%

Seborrhoeic dermatitis

Haemolytic anaemia

Haemoglobin decreased

Hyperbilirubinaemia

Dry skin

Medical observation

Thrombocytopenia

Reticulocyte count increased

Dermatitis diaper

Rash maculo-papular

Gamma-glutamyl transferase increased

Seborrhoea

Aspartate Aminotransferase Increased

Tachypnoea

Ankyloglossia Congenital

Vomiting

Conjucunctival Hemorrhage

Lethargy

Melanosis

Patent Ductus Arteriosus

Haematocrit Abnormal

Ventricular Hypertrophy

Eye Discharge

Anaemia

Haematocrit decreased

Infantile Vomiting

Erythema toxicum neonatorum

Skin Sensitisation

Bilirubin Conjugated Increased

Skin Hyperpigmentation

Rash Erythematous

Cough

Leukocytosis

Supraventricular Tachycardia

Atrial Septal Defect

Constipation

Infantile Colic

Candida Nappy Rash

Skin Candida

Sunburn

Respiratory Syncytial Virus Test Positive

Tremor

Umbilical Granuloma

Acne infantile

Viral Infection

Hyperkalaemia

Hypocalcaemia

Nasal Congestion

Milia

Supraventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

3.0 mg/kg Stannsoporfin

4.5mg/kg Stannsoporfin

Placebo

SHIFT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personalized light conditionExperimental Treatment1 Intervention

Participants will receive light exposure recommendations from the SHIFT mobile application based on their activity levels. Participants will follow these recommendations over the course of two weeks.

Group II: Non-personalized light conditionActive Control1 Intervention

Participants will receive light exposure recommendations from the SHIFT mobile application based on their habitual sleep schedule. Participants will follow these recommendations over the course of two weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phototherapy

2021

Completed Phase 4

~750

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,949 Total Patients Enrolled

American Academy of Sleep MedicineOTHER

22 Previous Clinical Trials

2,588 Total Patients Enrolled

Media Library

Phototherapy (Phototherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05186233 — N/A

Shift Work Sleep Disorder Research Study Groups: Non-personalized light condition, Personalized light condition

Shift Work Sleep Disorder Clinical Trial 2023: Phototherapy Highlights & Side Effects. Trial Name: NCT05186233 — N/A

Phototherapy (Phototherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05186233 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for this research trial?

"Affirmative. The information found on clinicaltrials.gov affirms that this research project, which was initially advertised on April 18th 2022, is actively enlisting participants. Around 50 patients are needed from a single site to fulfil the requirements of the study."

Answered by AI

How many subjects are currently enrolled in this research endeavor?

"Indeed, clinicaltrials.gov's data suggests that this particular trial is currently recruiting patients which were initially posted on April 18th 2022. The last time the listing was updated was June 23rd of this year and 50 participants are needed from a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Consumer Sleep Technology to Treat Shift Work Disorder

Philip Cheng 2022. "Use of Consumer Sleep Technology to Treat Shift Work Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05186233.