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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 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
7%
Haemolytic anaemia
7%
Haemoglobin decreased
7%
Hyperbilirubinaemia
7%
Dry skin
7%
Medical observation
7%
Thrombocytopenia
7%
Reticulocyte count increased
7%
Dermatitis diaper
7%
Rash maculo-papular
7%
Gamma-glutamyl transferase increased
7%
Seborrhoea
3%
Conjucunctival Hemorrhage
3%
Anaemia
3%
Eye Discharge
3%
Vomiting
3%
Tachypnoea
3%
Aspartate Aminotransferase Increased
3%
Haematocrit Abnormal
3%
Ankyloglossia Congenital
3%
Lethargy
3%
Melanosis
3%
Patent Ductus Arteriosus
3%
Ventricular Hypertrophy
3%
Haematocrit decreased
3%
Infantile Vomiting
3%
Erythema toxicum neonatorum
3%
Skin Sensitisation
3%
Bilirubin Conjugated Increased
3%
Skin Hyperpigmentation
3%
Rash Erythematous
3%
Cough
3%
Leukocytosis
3%
Supraventricular Tachycardia
3%
Atrial Septal Defect
3%
Constipation
3%
Infantile Colic
3%
Candida Nappy Rash
3%
Skin Candida
3%
Sunburn
3%
Respiratory Syncytial Virus Test Positive
3%
Tremor
3%
Umbilical Granuloma
3%
Acne infantile
3%
Viral Infection
3%
Hyperkalaemia
3%
Hypocalcaemia
3%
Nasal Congestion
3%
Milia
3%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
305 Previous Clinical Trials
2,107,930 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
~11 spots leftby Jan 2025