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Bipolar DisorderVATMANNCT01818622

Virtual Darkness as Additive Treatment in Mania

A study testing Blue-blocking goggles/screens and Clear-lensed goggles in people with Bipolar Disorder and Mania, run by Helse Fonna at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder, Mania
What is being tested?
Blue-blocking goggles/screens and Clear-lensed goggles
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
69 participants
Where
2 sitesNorway
Study dates
Feb 2012to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Inpatients
  • Diagnosis of DSM IV-TR of Bipolar I or Bipolar II disorder with current manic episode as verified by the semistructured interview MINI plus
  • Ability to comply with the protocol
  • Willingness to participate in the study
  • Delayed written informed consent at discharge
  • Written informed consent

Who cannot join

  • Inability to comply with the protocol
  • Severe retinal damage, cataract or corneal damage on both eyes
  • Daily use of NSAIDS
  • Daily use of betablockers
  • Daily use of calcium-antagonists
  • NON-BIPOLAR CONTROLS
Show all 14Show fewer
  • Working night shift
  • Diagnosed with bipolar disorder or single manic episode
  • Severe retinal damage, cataract or corneal damage on both eyes
  • Daily use of alcohol
  • Daily use of benzodiazepines
  • Daily use of NSAIDS
  • Daily use of betablockers
  • Daily use of calcium-antagonists

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Haugesund Hospital and Haugaland District Psychiatric Hospital

    Haugesund, 5521

  • Valen Hospital and Folgfonn District Hospital

    Valen, 5451

Other trials in Norway

About this study

Official title: Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial

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.

Read the 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.

Being tested
Blue-blocking goggles/screens, Clear-lensed goggles
Keywords
Bipolar disorder, Mania, Blue-blockers, Virtual darkness therapy, Actigraphy, Randomized controlled trial
Medical subject headings
Bipolar Disorder, Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blue-blocking goggles/screensDevice

    Also called Goggles from LowBlueLights.com, several different designs, Screens from Ganta Trading 047 Orange-red

    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 gogglesDevice

    Also called Uvex Genesis, Cocraft Safety Glasses 40-7362, 3M Refine 300 PC AS/AF

    Clear lensed safety eyewear. Patients may choose model for best comfort.

Study groups in NCT01818622
Study groupRoleWhat they receive
Patient-group blue-blockersExperimentalN= 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.
Receives: Device: Blue-blocking goggles/screens
Patient group clear-lensed gogglesPlacebo comparatorN= 21 (Patient group) clear-lensed goggles from 06 p.m. to 08 a.m. in addition to TAU.
Receives: Device: Clear-lensed goggles
Non-bipolar control-group blue-blockersExperimentalN= 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).
Receives: Device: Blue-blocking goggles/screens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Young Mania Rating Scale (YMRS) score

    The YMRS-score is assessed daily at 12 a.m. for 7 days

    Measured: Change from baseline in YMRS score after 7 days

Secondary outcomes (1)

  1. 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)

    Measured: Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2013 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01818622
Sponsor's protocol ID
911678
Other IDs
2011/1668
Acronym
VATMAN
Status last verified
Mar 2015
First submitted
22 Mar 2013
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17637502

  • 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.

    PubMed 17351786

  • 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.

    PubMed 11487664

  • 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.

    PubMed 15713707

  • 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.

    PubMed 16842544

Questions about this trial

What is this clinical trial studying?

A study testing Blue-blocking goggles/screens and Clear-lensed goggles in people with Bipolar Disorder and Mania, run by Helse Fonna at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Young Mania Rating Scale (YMRS) score (time frame: Change from baseline in YMRS score after 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01818622, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015; AzTrials last refreshed its copy on 1 Nov 2026.

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