NCT02653040

Brief Summary

The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 15, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

May 3, 2018

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

December 4, 2015

Last Update Submit

May 2, 2018

Conditions

Keywords

LightingInpatientsRecoverySleep

Outcome Measures

Primary Outcomes (1)

  • Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)

    Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

Secondary Outcomes (4)

  • Depressive symptoms on the Major depression inventory (MDI)

    Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

  • Well-being on the World Health Organization measure of well-being (WHO-5)

    Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

  • Qualitative assessment using a custom made questionnaire

    Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

  • Sleep diary

    Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

Other Outcomes (3)

  • Time to discharge

    Assessed through study completion, an average of 1 month, up to 6 months

  • Involuntary restraints

    Assessed through study completion, an average of 1 month, up to 6 months

  • Use of medication from logged activity in the electronic medical record

    Assessed through study completion, an average of 1 month, up to 6 months

Study Arms (2)

Dynamic lighting

EXPERIMENTAL

Indoor lighting with low-lux no-blue wavelengths at night.

Other: Dynamic lighting

Treatment as usual

NO INTERVENTION

Characterized by full white light with little variation through a day cyclus.

Interventions

Intervention is rooms with light settings imitating natural light conditions with white light at day and low-lux no-blue light at night: 07am-10am: white light, increasing intensity 10am-07pm: white light, full intensity 07pm-11pm: no blue wavelength, low intensity 11pm-07am: no blue wavelength, very low intensity

Also known as: Illumination, lighting design, lighting environment
Dynamic lighting

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission

You may not qualify if:

  • Inability to provide written consent
  • Mania

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Affective Disorders, Aarhus University Hospital, Risskov

Risskov, Jylland, 8240, Denmark

Location

Related Publications (2)

  • Bedrosian TA, Nelson RJ. Influence of the modern light environment on mood. Mol Psychiatry. 2013 Jul;18(7):751-7. doi: 10.1038/mp.2013.70. Epub 2013 May 28.

    PMID: 23711982BACKGROUND
  • LeGates TA, Fernandez DC, Hattar S. Light as a central modulator of circadian rhythms, sleep and affect. Nat Rev Neurosci. 2014 Jul;15(7):443-54. doi: 10.1038/nrn3743. Epub 2014 Jun 11.

    PMID: 24917305BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Interventions

Lighting

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Niels Okkels, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

January 12, 2016

Study Start

December 15, 2015

Primary Completion

January 15, 2017

Study Completion

March 15, 2018

Last Updated

May 3, 2018

Record last verified: 2017-10

Locations