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

NCT05797324 | Unknown

• 1 other identifier: 21A011
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Light therapy

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index

  Insomnia Severity Index (ISI, Pittsburgh Quality Index) - self-report questionnaire composed of 19 items assessing sleep quality

  Baseline and after 6 weeks of intervention

Secondary Outcomes (1)

• Change in salivary melatonin

  Baseline and after 6 weeks of intervention

Study Arms (2)

Luminette

EXPERIMENTAL

Patients without ocular contraindications undergo a Luminotherapy protocol (intermittent blue-enriched light therapy with Luminette 10000 lux equivalent) with morning or evening timing, depending on the circadian phase.

Other: Luminette

Sham

SHAM COMPARATOR

Control group (white light \<100 lux equivalent).

Other: Sham

Interventions

Luminette OTHER

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

Luminette

Sham OTHER

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

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary chronic insomnia
• Comorbid chronic insomnia
• Absence of pharmacological therapy of insomnia
• Absence of behavioural and cognitive treatment of insomnia
• Capacity to understand the study and adhere to the procedures
• Written informed consent

You may not qualify if:

• Secondary insomnia due to medical conditions or drug treatment
• Cerebral diseases
• Invalidating diseases
• Eye diseases that contraindicate the use of light therapy
• Psychiatric disorders
• Cognitive decline
• Working in night shifts during the last month before enrolment
• Impossibility to provide informed consent

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Ente Ospedaliero Cantonale, Ticino, Switzerland: collaborator

Study Sites (1)

Istituto Auxologico Italiano

Oggebbio, Italy

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Riccardo Cremascoli

CONTACT

+393497292068; r.cremascoli@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: November 17, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

IT (1)