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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/1668 | Other Identifier | Regional Ethics Committee North |
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| Name | Class |
|---|---|
| University of Bergen | OTHER |
| Helse Vest | OTHER |
| Moodnet | UNKNOWN |
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In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group.
Recent discoveries in neurophysiology has shown that "virtual darkness" is achievable by blocking blue wavelengths of light (Phelps, 2007). A newly discovered retinal photoreceptor called the Intrinsically photoresponsive retinal ganglion-cell (IpRGC) whose fibers directly synapses with the suprachiasmatic nucleus (SCN), responds only to a narrow band of wavelengths with highest sensitivity between 446 and 484 nm (Brainard et al., 2001; Berson 2007). Amber tinted goggles preserve normal nocturnal melatonin levels in light environments, which means that blocking of the blue wavelengths is perceived as virtual darkness to the SCN (Kayumov, 2005; Sasseville, 2006).
In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. The general feasibility of the method both in research and treatment will be evaluated. This is a multi-site study covering Helse Fonna Local Health Authority's catchment area wich serves a population of 120000 adults. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group. The study may contribute to develop a supplement to the current treatment in mania and may also generate new hypotheses about the underlying pathophysiological mechanisms in bipolar disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-group blue-blockers | Experimental | N= 21 Blue-blocking goggles/screens from 6 p.m. to 08 a.m. in addition to treatment as usual (TAU). The goggles may be taken of when going to bed and turning of the light. For consenting patients who are unable to use goggles according to the protocol blue-blocking screens covering light-sources will be used. |
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| Patient group clear-lensed goggles | Placebo Comparator | N= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU. |
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| Non-bipolar control-group blue-blockers | Experimental | N= 42 For baseline day 1-7: Actiwatch Spectrum worn at the wrist of dominant hand, day 8-14 continued wearing of Actiwatch spectrum + blue-blocking goggles from 6 p.m. to 08 a.m. In addition to selfreport forms described in the outcome section self report forms Horne-Ostberg Morningness-Eveningness Questionaire (HOMEQ)and Seasonal Pattern Assessment Questionaire (SPAQ). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue-blocking goggles/screens | Device | Goggles with amber tinted lenses, all model's transmittance spectra are identical. Goggles and screens are tested at Department of Physics and Technology, University of Bergen. Patients and non-bipolar controls choose model for best comfort. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Young Mania Rating Scale (YMRS) score | The YMRS-score is assessed daily at 12 a.m. for 7 days | Change from baseline in YMRS score after 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in motor activity measured by use of actigraphy, Actiwatch Spectrum device | Patient-groups wear Actiwatch Spectrum for 7 days. Non-bipolar controls wear Actiwatch Spectrum for 14 days (day 1-7 for baseline, day 8-14 with intervention) | Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) . |
| Measure | Description | Time Frame |
|---|---|---|
| For the non-bipolar control-group: self report forms Mood Visual Analog Scale, Positive And Negative Affect Schedule and Sleep Diary | 14 days | |
| Self-report form for patient's experience. | Self report form developed for the trial for patients experience with the intervention, wearing of Actiwatch Spectrum and general participation in the trial, and section for other comments. |
PATIENT GROUPS
Inclusion Criteria:
Exclusion Criteria:
NON-BIPOLAR CONTROLS
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Lund, PhD | University of Bergen, Moodnet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haugesund Hospital and Haugaland District Psychiatric Hospital | Haugesund | 5521 | Norway | |||
| Valen Hospital and Folgfonn District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17637502 | Background | Phelps J. Dark therapy for bipolar disorder using amber lenses for blue light blockade. Med Hypotheses. 2008;70(2):224-9. doi: 10.1016/j.mehy.2007.05.026. Epub 2007 Jul 16. | |
| 17351786 | Background | Berson DM. Phototransduction in ganglion-cell photoreceptors. Pflugers Arch. 2007 Aug;454(5):849-55. doi: 10.1007/s00424-007-0242-2. Epub 2007 Mar 10. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D055088 | Early Detection of Cancer |
| ID | Term |
|---|---|
| D042241 | Early Diagnosis |
| D003933 | Diagnosis |
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| Clear-lensed goggles | Device | Clear lensed safety eyewear. Patients may choose model for best comfort. |
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| At discharge |
| Self report form for non-bipolar controls on experience with intervention | 3 questions: 1)Did you notice any change during the intervention? 2)If yes in question 1)When did you first notice any change? 3)If yes in question 1)Describe the experience in own words | At end of intervention, day 14 |
| Valen |
| 5451 |
| Norway |
| 11487664 | Background | Brainard GC, Hanifin JP, Greeson JM, Byrne B, Glickman G, Gerner E, Rollag MD; New Collective Author. Action spectrum for melatonin regulation in humans: evidence for a novel circadian photoreceptor. J Neurosci. 2001 Aug 15;21(16):6405-12. doi: 10.1523/JNEUROSCI.21-16-06405.2001. |
| 15713707 | Background | Kayumov L, Casper RF, Hawa RJ, Perelman B, Chung SA, Sokalsky S, Shapiro CM. Blocking low-wavelength light prevents nocturnal melatonin suppression with no adverse effect on performance during simulated shift work. J Clin Endocrinol Metab. 2005 May;90(5):2755-61. doi: 10.1210/jc.2004-2062. Epub 2005 Feb 15. |
| 16842544 | Background | Sasseville A, Paquet N, Sevigny J, Hebert M. Blue blocker glasses impede the capacity of bright light to suppress melatonin production. J Pineal Res. 2006 Aug;41(1):73-8. doi: 10.1111/j.1600-079X.2006.00332.x. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |