Blue-blocking glasses for manic symptoms in bipolar I
Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder
This project will test whether wearing blue-blocking glasses for seven days helps reduce manic symptoms and improve sleep in adults hospitalized with bipolar I manic episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 1 site (Paris, France) |
| Trial ID | NCT07194278 on ClinicalTrials.gov |
What this trial studies
The study examines feasibility and preliminary clinical effects of amber (blue-blocking) glasses worn continuously for seven days by adults hospitalized for a bipolar I manic episode. Participants are recruited from the adult psychiatry sector G22 at GHU-Paris (Maison Blanche - Bichat), complete clinician‑administered questionnaires at day 0, day 3, and day 7, and wear an actigraphy watch throughout the intervention. Primary outcomes focus on feasibility measures (recruitment, participation, adherence, and material feasibility) and acceptability, while secondary outcomes measure manic symptom severity, sleep parameters, global functioning, and suicidal ideation. Self-reported satisfaction and all clinical indicators are collected at the end of the seven-day participation period.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) hospitalized at the study site with a DSM-5 manic episode in the context of bipolar I disorder who can provide informed consent and do not have contraindicating eye conditions or pregnancy.
Not a fit: Patients who cannot consent, require urgent medical care, have severe eye disease or prior eye trauma, or are pregnant or breastfeeding are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, wearing blue-blocking glasses could offer a low-risk, easy-to-use way to reduce manic symptoms and improve sleep and functioning during acute manic episodes.
How similar studies have performed: Small randomized trials and case reports have suggested that blue-blocking glasses can quickly reduce manic symptoms, but the overall evidence is limited and requires larger confirmatory studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old * Patient with a type 1 bipolar disorder presenting a manic episode according to the DSM-5 TR, with or without associated psychotic disorders. Exclusion Criteria: * Patient who did not agree to participate to the study * Patient unable to be informed or understand the course of the study * Patient with severe eye problem or with an history of trauma affecting the eyes * Pregnant or breastfeeding women * Patient in need of urgent care
Where this trial is running
Paris, France
- Secteur de psychiatrie adulte G22-G23-G24 — Paris, France, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.