Impact of Bright Light Therapy on Prader-Willi Syndrome

Body Weight Clinical Trial

— PWS-LT  

Official title:

A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939453
• Other study ID #: Study 2022-08-12-MMC
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Maimonides Medical Center
• Contact: Otuwe Anya, BA
• Phone: 718-283-8170
• Email: oanya[@]maimonidesmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

Description:

This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis.

Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PWS confirmed by genetic testing

• Score of 12 or above on the Epworth Sleepiness Scale (ESS).

Exclusion Criteria:

• Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications

• A history of previous treatment with LT

• Patients presenting with active psychosis or mania

Related Conditions & MeSH terms

• Behavior
• Body Weight
• Disorders of Excessive Somnolence
• Excessive Daytime Sleepiness
• Hyperphagia
• Mood
• Prader-Willi Syndrome
• Sleepiness
• Syndrome

Intervention

Other:
• Sham Light
Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
• Bright Light Therapy
Bright Light Therapy will be provided using light box with an artificial full spectrum lamp at a distance of at least 70cm but no greater than 90cm.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Maimonides Medical Center	Foundation for Prader-Willi Research

Country where clinical trial is conducted

United States, 

References & Publications (20)

Adhikari P, Pradhan A, Zele AJ, Feigl B. Supplemental light exposure improves sleep architecture in people with type 2 diabetes. Acta Diabetol. 2021 Sep;58(9):1201-1208. doi: 10.1007/s00592-021-01712-y. Epub 2021 Apr 14. — View Citation

De Cock VC, Diene G, Molinas C, Masson VD, Kieffer I, Mimoun E, Tiberge M, Tauber M. Efficacy of modafinil on excessive daytime sleepiness in Prader-Willi syndrome. Am J Med Genet A. 2011 Jul;155A(7):1552-7. doi: 10.1002/ajmg.a.34047. Epub 2011 Jun 10. — View Citation

Fetveit A, Bjorvatn B. Bright-light treatment reduces actigraphic-measured daytime sleep in nursing home patients with dementia: a pilot study. Am J Geriatr Psychiatry. 2005 May;13(5):420-3. doi: 10.1176/appi.ajgp.13.5.420. — View Citation

Figueiro MG. Delayed sleep phase disorder: clinical perspective with a focus on light therapy. Nat Sci Sleep. 2016 Apr 6;8:91-106. doi: 10.2147/NSS.S85849. eCollection 2016. — View Citation

Fisher PM, Madsen MK, Mc Mahon B, Holst KK, Andersen SB, Laursen HR, Hasholt LF, Siebner HR, Knudsen GM. Three-week bright-light intervention has dose-related effects on threat-related corticolimbic reactivity and functional coupling. Biol Psychiatry. 2014 Aug 15;76(4):332-9. doi: 10.1016/j.biopsych.2013.11.031. Epub 2013 Dec 19. — View Citation

Gillett ES, Perez IA. Disorders of Sleep and Ventilatory Control in Prader-Willi Syndrome. Diseases. 2016 Jul 8;4(3):23. doi: 10.3390/diseases4030023. — View Citation

Ito T, Yamadera H, Ito R, Endo S. [Effects of bright light on cognitive disturbances in Alzheimer-type dementia]. Nihon Ika Daigaku Zasshi. 1999 Aug;66(4):229-38. doi: 10.1272/jnms.66.229. Japanese. — View Citation

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. — View Citation

Lassi G, Priano L, Maggi S, Garcia-Garcia C, Balzani E, El-Assawy N, Pagani M, Tinarelli F, Giardino D, Mauro A, Peters J, Gozzi A, Grugni G, Tucci V. Deletion of the Snord116/SNORD116 Alters Sleep in Mice and Patients with Prader-Willi Syndrome. Sleep. 2016 Mar 1;39(3):637-44. doi: 10.5665/sleep.5542. — View Citation

McCune AM, Lundgren JD. Bright light therapy for the treatment of night eating syndrome: A pilot study. Psychiatry Res. 2015 Sep 30;229(1-2):577-9. doi: 10.1016/j.psychres.2015.07.079. Epub 2015 Jul 29. — View Citation

Pail G, Huf W, Pjrek E, Winkler D, Willeit M, Praschak-Rieder N, Kasper S. Bright-light therapy in the treatment of mood disorders. Neuropsychobiology. 2011;64(3):152-62. doi: 10.1159/000328950. Epub 2011 Jul 29. — View Citation

Patel VP, Patroneva A, Glaze DG, Davis Ms K, Merikle E, Revana A. Establishing the content validity of the Epworth Sleepiness Scale for Children and Adolescents in Prader-Willi syndrome. J Clin Sleep Med. 2022 Feb 1;18(2):485-496. doi: 10.5664/jcsm.9632. — View Citation

Pullen LC, Picone M, Tan L, Johnston C, Stark H. Cognitive Improvements in Children with Prader-Willi Syndrome Following Pitolisant Treatment-Patient Reports. J Pediatr Pharmacol Ther. 2019 Mar-Apr;24(2):166-171. doi: 10.5863/1551-6776-24.2.166. — View Citation

Rastad C, Ulfberg J, Lindberg P. Improvement in Fatigue, Sleepiness, and Health-Related Quality of Life with Bright Light Treatment in Persons with Seasonal Affective Disorder and Subsyndromal SAD. Depress Res Treat. 2011;2011:543906. doi: 10.1155/2011/543906. Epub 2011 Jun 13. — View Citation

Sene-Fiorese M, Duarte FO, de Aquino Junior AE, Campos RM, Masquio DC, Tock L, de Oliveira Duarte AC, Damaso AR, Parizotto NA, Bagnato VS. The potential of phototherapy to reduce body fat, insulin resistance and "metabolic inflexibility" related to obesity in women undergoing weight loss treatment. Lasers Surg Med. 2015 Oct;47(8):634-42. doi: 10.1002/lsm.22395. Epub 2015 Jul 29. — View Citation

Soreca I. The role of circadian rhythms in Obstructive Sleep Apnea symptoms and novel targets for treatment. Chronobiol Int. 2021 Sep;38(9):1274-1282. doi: 10.1080/07420528.2021.1929281. Epub 2021 May 24. — View Citation

Srisurapanont K, Samakarn Y, Kamklong B, Siratrairat P, Bumiputra A, Jaikwang M, Srisurapanont M. Blue-wavelength light therapy for post-traumatic brain injury sleepiness, sleep disturbance, depression, and fatigue: A systematic review and network meta-analysis. PLoS One. 2021 Feb 4;16(2):e0246172. doi: 10.1371/journal.pone.0246172. eCollection 2021. — View Citation

Stucky B, Clark I, Azza Y, Karlen W, Achermann P, Kleim B, Landolt HP. Validation of Fitbit Charge 2 Sleep and Heart Rate Estimates Against Polysomnographic Measures in Shift Workers: Naturalistic Study. J Med Internet Res. 2021 Oct 5;23(10):e26476. doi: 10.2196/26476. — View Citation

Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. doi: 10.1001/jamaneurol.2016.5192. — View Citation

Wirz-Justice A, Bader A, Frisch U, Stieglitz RD, Alder J, Bitzer J, Hosli I, Jazbec S, Benedetti F, Terman M, Wisner KL, Riecher-Rossler A. A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression. J Clin Psychiatry. 2011 Jul;72(7):986-93. doi: 10.4088/JCP.10m06188blu. Epub 2011 Apr 5. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression- Improvement (CGI-I)	A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.	8 Weeks
Secondary	Aberrant Behavior Checklist	Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).	8 Weeks
Secondary	Self-Injury Trauma scale	Scores of 5 or greater were found to be indicative of borderline personality disorder. Part 1 is ranking based on the number of wounds 1=one would (common in a mild self-injurious behavior but rare in a severe case) 2=two or four wounds (common) and 3=five or more wounds (rare). Injury severity is scored on a subjective basis with labels such as "mild" "moderate" and "severe" accompanied by descriptions of the observed state of the anatomy. Part 3 is the Estimate of Current Risk.	8 Weeks
Secondary	Modified Overt Aggression Scale	Four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes.[1] The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others	8 Weeks