Virtual Darkness as Additive Treatment in Mania
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Blue-blocking goggles/screens; Clear-lensed goggles
Intervention type(s): Device; Device
Intervention description(s): 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.; Clear lensed safety eyewear. Patients may choose model for best comfort.
Other intervention name(s): Goggles from LowBlueLights.com, several different designs; Screens from Ganta Trading 047 Orange-red; Uvex Genesis; Cocraft Safety Glasses 40-7362; 3M Refine 300 PC AS/AF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bipolar disorder; Mania; Blue-blockers; Virtual darkness therapy; Actigraphy; Randomized controlled trial