NCT Number: NCT01818622
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Haugesund Hospital and Haugaland District Psychiatric Hospital, Haugesund, Norway
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
PATIENT GROUPS
Inclusion criteria
Exclusion criteria
NON-BIPOLAR CONTROLS
Inclusion criteria
Exclusion criteria
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.
Other names: Goggles from LowBlueLights.com, several different designs, Screens from Ganta Trading 047 Orange-red
Clear lensed safety eyewear. Patients may choose model for best comfort.
Other names: Uvex Genesis, Cocraft Safety Glasses 40-7362, 3M Refine 300 PC AS/AF
Time frame: Change from baseline in YMRS score after 7 days
The YMRS-score is assessed daily at 12 a.m. for 7 days
Time frame: Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) .
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)
Time frame: 14 days
Time frame: At discharge
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.
Time frame: At end of intervention, day 14
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
Helse Fonna
Other
Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial
Acronym: VATMAN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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