Prader-Willi SyndromePWS-LTNCT05939453
Impact of Bright Light Therapy on Prader-Willi Syndrome
A study testing Bright Light Therapy in people with Prader-Willi Syndrome and Excessive Daytime Sleepiness, run by Maimonides Medical Center at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 6 to 88 years
- Conditions the study is for
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia
- What is being tested?
- Bright Light Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 88 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of PWS confirmed by genetic testing
- Score of 12 or above on the Epworth Sleepiness Scale (ESS).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
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
Read the detailed 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.
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight, Mood, Behavior
- Being tested
- Sham Light, Bright Light Therapy
- Keywords
- Light Therapy, Aberrant Behavior Checklist, Clinical Global Impression- Improvement, Fitbit, Actigraphy reports, Epworth Sleepiness Scale, Hyperphagia Questionnaire (HQCT), Modified Overt Aggression Scale (MOAS)
- Medical subject headings
- Prader-Willi Syndrome, Disorders of Excessive Somnolence, Hyperphagia, Body Weight, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham LightOther
Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
Bright Light TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Light | Sham comparator | Not described Receives: Other: Sham Light |
| Light Therapy | Experimental | Not described Receives: Other: Bright Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (3)
Aberrant Behavior Checklist
Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).
Measured: 8 Weeks
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.
Measured: 8 Weeks
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
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Prader-Willi Research
- Responsible party
- Sponsor
- Investigators
- Edward Yi, MD, Principal investigator, Maimonides Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939453
- Sponsor's protocol ID
- Study 2022-08-12-MMC
- Acronym
- PWS-LT
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21747994Videnovic 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.
PubMed 28241159Johns 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.
PubMed 1798888Lassi 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.
PubMed 26446116Pail 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.
PubMed 21811085Ito 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.
PubMed 10466338Srisurapanont 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.
PubMed 33539446Adhikari 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.
PubMed 33851274Sene-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.
PubMed 26220050Patel 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.
PubMed 34437052De 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.
PubMed 21671379Pullen 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.
PubMed 31019411Gillett ES, Perez IA. Disorders of Sleep and Ventilatory Control in Prader-Willi Syndrome. Diseases. 2016 Jul 8;4(3):23. doi: 10.3390/diseases4030023.
PubMed 28933403Fetveit 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.
PubMed 15879592Fisher 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.
PubMed 24439303
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT05939453
- Acronym / sponsor ID
- PWS-LT / Study 2022-08-12-MMC
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight, Mood, Behavior
- Keywords
- Light Therapy, Aberrant Behavior Checklist, Clinical Global Impression- Improvement, Fitbit, Actigraphy reports, Epworth Sleepiness Scale, Hyperphagia Questionnaire (HQCT), Modified Overt Aggression Scale (MOAS)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Collaborators
- Foundation for Prader-Willi Research
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Light | Sham comparator | Other: Sham Light |
| Light Therapy | Experimental | Other: Bright Light Therapy |
Who may qualify
- Ages
- 6 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of PWS confirmed by genetic testing
- Score of 12 or above on the Epworth Sleepiness Scale (ESS).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham LightSham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm. | Other | Sham Light |
| Bright Light TherapyBright 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. | Other | Light Therapy |
Primary outcome
Clinical Global Impression- Improvement (CGI-I)
Time frame: 8 Weeks
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.
3 secondary outcomes
Aberrant Behavior Checklist
Time frame: 8 Weeks
Self-Injury Trauma scale
Time frame: 8 Weeks
Modified Overt Aggression Scale
Time frame: 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 21747994Rastad 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.
- Background: PubMed 28241159Videnovic 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.
- Background: PubMed 1798888Johns 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.
- Background: PubMed 26446116Lassi 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.
- Background: PubMed 21811085Pail 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.
- Background: PubMed 10466338Ito 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.
- Background: PubMed 33539446Srisurapanont 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.
- Background: PubMed 33851274Adhikari 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.
- Background: PubMed 26220050Sene-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.
- Background: PubMed 34437052Patel 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.
- Background: PubMed 21671379De 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.
- Background: PubMed 31019411Pullen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Yi, MD principal investigator
Maimonides Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy in people with Prader-Willi Syndrome and Excessive Daytime Sleepiness, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression- Improvement (CGI-I) (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05939453, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.