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

Primary Purpose

Insomnia Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Luminette
Sham
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic focused on measuring Light therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Istituto Auxologico ItalianoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Luminette

Sham

Arm Description

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.

Control group (white light <100 lux equivalent).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in salivary melatonin
Salivary melatonin - evening 5-point wipes (DLMO, Elisa)

Full Information

First Posted
March 21, 2023
Last Updated
April 4, 2023
Sponsor
Istituto Auxologico Italiano
Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation, Ente Ospedaliero Cantonale, Ticino, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT05797324
Brief Title
Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia.
Acronym
Luminoterapia
Official Title
Multicenter Study on the Role of Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia Through Circadian Phase Modification.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation, Ente Ospedaliero Cantonale, Ticino, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. STUDY DESIGN AND METHODS With regard to the study in question, it should be noted that: the study is a prospective multicentre randomized single-blind controlled trial the duration of the study is expected to be 3 years with a duration of enrollment of 2 and a half years and a minimum clinical follow-up of 3 months The study will be divided into two evaluations, an initial evaluation (Time 0, T0) where the patients will be enrolled and all the measurements required before treatment with light therapy will be performed, and a final evaluation after 6 weeks of treatment with light therapy effective or sham (Time 1, T1), where the measurements performed at T0 will be repeated. Both assessments will be performed at the Sleep Medicine outpatient clinic. TIME T0 The diagnosis of primary chronic or comorbid insomnia will be made during the semi-structured sleep interview by a physician expert in sleep medicine, according to DSM V criteria, supported by clinical scales (Insomnia Severity Index, Pittsburgh Quality Index). The presence of mood/behavioral disorders or cognitive deficits will also be excluded (Beck, Stai, Mini Mental Scale Examination). A home polysomnography will be performed to rule out the presence of sleep apnea disorder or periodic limb movement syndrome during sleep Circadian parameters (chronotype, Mid sleep, circadian phase, phase angle) will be evaluated in basal conditions through clinical scales (Morning Eveningness Questionnaire, Light diet), measurement of salivary melatonin using evening 5-point wipes at home (DLMO, Elisa) and the actigraphic registration extended for 7 days. The associations between the circadian phase and the various phenotypes of primary or comorbid insomnia will be then evaluated, according to the duration and the severity of insomnia. Patients without ocular contraindications will then undergo a Luminotherapy protocol (intermittent blue-enriched light therapy with Luminette 10000 lux equivalent) with morning or evening timing, depending on the circadian phase, or sham treatment (control subgroup; white light <100 lux equivalent). Patients will be randomly assigned to one of two conditions (treatment and sham). The randomization list will be generated with a simple randomization method through the use of a "Random number generator" software available at www.regione.emilia-romagna.t/sin_info/generatore. The algorithm used in this site coincides with a Lehmer generator (multiplicative congruential generator). Allocation concealment is guaranteed by a central randomization in a distant and independent location with respect to the recruitment site. TIME T1 > After 6 consecutive weeks of home light therapy, patients will be re-evaluated with the same somnometry battery used at study entry. Furthermore, the actigraphic monitoring and the dosage of salivary melatonin will be repeated, to evaluate the variations of the circadian phase and of the sleep-wake pattern after light therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic
Keywords
Light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Luminette
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Control group (white light <100 lux equivalent).
Intervention Type
Other
Intervention Name(s)
Luminette
Intervention Description
Luminotherapy protocol (intermittent blue-enriched light therapy with Luminette 10000 lux equivalent) with morning or evening timing, depending on the circadian rhythm
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham protocol (white light <100 lux equivalent).
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
Insomnia Severity Index (ISI, Pittsburgh Quality Index) - self-report questionnaire composed of 19 items assessing sleep quality
Time Frame
Baseline and after 6 weeks of intervention
Secondary Outcome Measure Information:
Title
Change in salivary melatonin
Description
Salivary melatonin - evening 5-point wipes (DLMO, Elisa)
Time Frame
Baseline and after 6 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riccardo Cremascoli
Phone
+393497292068
Email
r.cremascoli@auxologico.it
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Oggebbio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Cremascoli, MD
Email
r.cremascoli@auxologico.it

12. IPD Sharing Statement

Learn more about this trial

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

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