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Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia.

NCT05797324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-04-06

No results posted yet for this study

Summary

Some evidence indicates that circadian rhythm may play a role in the pathophysiology of insomnia disorder. This single-blind randomized controlled multicentre prospective study aims to evaluate the possible therapeutic effect of light therapy in modulating the clinical phenotype of patients affected by chronic primary and comorbid insomnia, through the modification of the circadian phase.

Conditions

  • Insomnia Chronic

Interventions

OTHER

Luminette

Luminotherapy protocol (intermittent blue-enriched light therapy with Luminette 10000 lux equivalent) with morning or evening timing, depending on the circadian rhythm

OTHER

Sham

Sham protocol (white light \<100 lux equivalent).

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    collaborator OTHER

  • Ente Ospedaliero Cantonale, Ticino, Switzerland

    collaborator OTHER

  • Istituto Auxologico Italiano

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797324 on ClinicalTrials.gov