Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT04612192
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Therapy for Chronic Insomnia in General Practice
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Insolux
Brief Summary:
* Sleep disorders, especially insomnia
* Attention deficits (or disorders), daytime somnolence and drug dependence
* The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice
* Attention deficits (or disorders), daytime somnolence and drug dependence
* The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice
Detailed Description:
Insomnia affects 15 to 20% of the general French adult population and increases with age. General practitioners (GPs) are the first confronted to sleep disorders, especially insomnia.
Cognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed.
Light not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions.
The administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase.
Study will be conduct on an outpatient basis in general practice
Cognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed.
Light not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions.
The administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase.
Study will be conduct on an outpatient basis in general practice
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: