Impact of Bright Light Therapy on Prader-Willi Syndrome

NCT05939453 | Recruiting DMC

• 1 other identifier: Study 2022-08-12-MMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Behavior; Prader-Willi Syndrome; Hyperphagia; Body Weight; Mood; Excessive Daytime Sleepiness

Keywords

Light Therapy; Aberrant Behavior Checklist; Clinical Global Impression- Improvement; Fitbit; Actigraphy reports; Epworth Sleepiness Scale; Hyperphagia Questionnaire (HQCT); Modified Overt Aggression Scale (MOAS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Aberrant Behavior Checklist

  8 Weeks

• Self-Injury Trauma scale

  8 Weeks

• Modified Overt Aggression Scale

  8 Weeks

Study Arms (2)

Sham Light

SHAM COMPARATOR

Other: Sham Light

Light Therapy

EXPERIMENTAL

Other: Bright Light Therapy

Interventions

Sham Light OTHER

Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.

Sham Light

Bright Light Therapy OTHER

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.

Light Therapy

Eligibility Criteria

• Age: 6 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PWS confirmed by genetic testing
• Score of 12 or above on the Epworth Sleepiness Scale (ESS).

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimonides Medical Center: lead
• Foundation for Prader-Willi Research: collaborator

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 21747994 BACKGROUND

• 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.

  PMID: 28241159 BACKGROUND

• 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.

  PMID: 1798888 BACKGROUND

• 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.

  PMID: 26446116 BACKGROUND

• 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.

  PMID: 21811085 BACKGROUND

• 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.

  PMID: 10466338 BACKGROUND

• 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.

  PMID: 33539446 BACKGROUND

• 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.

  PMID: 33851274 BACKGROUND

• 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.

  PMID: 26220050 BACKGROUND

• 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.

  PMID: 34437052 BACKGROUND

• 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.

  PMID: 21671379 BACKGROUND

• 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.

  PMID: 31019411 BACKGROUND

• 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.

  PMID: 28933403 BACKGROUND

• 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.

  PMID: 15879592 BACKGROUND

• 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.

  PMID: 24439303 BACKGROUND

• 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.

  PMID: 21535997 BACKGROUND

• 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.

  PMID: 26239768 BACKGROUND

• 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.

  PMID: 27110143 BACKGROUND

• 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.

  PMID: 34027758 BACKGROUND

• 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.

  PMID: 34609317 BACKGROUND

MeSH Terms

Conditions

Prader-Willi Syndrome; Disorders of Excessive Somnolence; Hyperphagia; Body Weight; Behavior

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Edward Yi, MD

  Maimonides Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayank Kumar, PhD

CONTACT

718-283-8170; maykumar@maimo.org

Theresa Jacob, MPH, PhD

CONTACT

718-283-7162; tjacob@maimonidesmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: July 11, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)