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Phototherapy for Shift Work Sleep Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Henry Ford Columbus Medical Center, Novi, MIShift Work Sleep DisorderPhototherapy - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Shift Work Sleep Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Benzyl Peroxide
1
NBUVB phototherapy
1
Poziotinib

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Within two days of treatment for a duration of 24 hours

Within one week of post-treatment
Daytime sleepiness
Insomnia
Hour 24
Dim light melatonin onset

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Benzyl Peroxide
2
NBUVB phototherapy
2
Poziotinib

Side Effects for

4.5mg/kg Stannsoporfin
16%Erythema
13%Cardiac murmur
10%Dry skin
10%Reticulocyte count increased
6%Congenital naevus
6%Erythema toxicum neonatorum
6%Haematocrit decreased
3%Fat Tissue Increased
3%Nasal Congestion
3%Papule
3%Penile Haemorrhage
3%Otitis Media
3%Umbilical hernia
3%Milia
3%Platelet Count Decreased
3%Bacterial sepsis
3%Meningitis viral
3%Sepsis
3%Blood Bilirubin Increased
3%Red Blood Cell Count Decreased
3%Hypercalcaemia
3%Hypotonia
3%Jaundice Neonatal
3%Generalised Erythema
3%Rash Erythematous
3%Hyperbilirubinaemia
3%Skin Abrasion
3%Exfoliative Rash
3%Thrombocytopenia
3%Ecchymosis
3%Bacterial Sepsis
3%Neutrophil Count Decreased
3%Haemoglobin decreased
3%Abnormal Loss Of Weight
3%Cough
3%Acne infantile
3%Rash
3%Rash maculo-papular
3%Seborrhoea
3%Seborrhoeic dermatitis
3%Hydrocele
3%Middle Ear Effusion
3%Retinal Haemorrhage
3%Strabismus
3%Vomiting
3%Injection Site Erythema
3%Fungal Infection
3%Meningitis Viral
3%Aspartate Aminotransferase Increased
3%Blood Bicarbonate Decreased
3%White Blood Cell Count Increased
3%Feeding Intolerance
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01887327) in the 4.5mg/kg Stannsoporfin ARM group. Side effects include: Erythema with 16%, Cardiac murmur with 13%, Dry skin with 10%, Reticulocyte count increased with 10%, Congenital naevus with 6%.

Trial Design

2 Treatment Groups

Non-personalized light condition
1 of 2
Personalized light condition
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Phototherapy · No Placebo Group · N/A

Personalized light condition
Behavioral
Experimental Group · 1 Intervention: Phototherapy · Intervention Types: Behavioral
Non-personalized light condition
Behavioral
ActiveComparator Group · 1 Intervention: Phototherapy · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phototherapy
2021
Completed Phase 4
~750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within two days of treatment for a duration of 24 hours

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
270 Previous Clinical Trials
2,014,758 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
18 Previous Clinical Trials
2,289 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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