Back to resultsVR in Diabetic Polyneuropathy
Primary Purpose
Diabetic Polyneuropathy
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Virtual Reality application
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Polyneuropathy
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 70 years old
- Able to speak Dutch/French
- Continuing usual care regarding medication use 3 weeks prior and during study participation
- Diagnosis of DPN for 6 months or longer, confirmed on EMG
Exclusion Criteria:
- History of seizures/epilepsia
- Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
- shift workers
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality
Control
Arm Description
Virtual Reality will be provided to all participants, just before sleeping.
No specific intervention will be provided.
Outcomes
Primary Outcome Measures
Change in sleep efficiency between experimental and control intervention.
Measured with actigraphy.
Change in number of awakenings during the night between experimental and control intervention.
Measured with actigraphy.
Secondary Outcome Measures
Change in subjective sleep quality between experimental and control intervention.
Measured with the Pittsburgh Sleep Quality Index (ranging from 0-21 with higher scores a poorer sleep quality).
Change in pain intensity reporting between experimental and control intervention.
Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity.
Pain catastrophizing
Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing.
Anxiety and depressive symptoms
Measured with the Hospital Anxiety and Depression Scale
Change in clinical status
Measured with the Global perceived effect
Any side effects of the experimental intervention
Nature, severity and impact of insomnia
Measured with the Insomnia Severity Index
Full Information
NCT ID
NCT04325347
First Posted
March 16, 2020
Last Updated
January 28, 2021
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04325347
Brief Title
VR in Diabetic Polyneuropathy
Official Title
Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is an experimental single centre study investigating the effect of VR on overall sleep quality and number of awakenings in patients with diabetic polyneuropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Virtual Reality will be provided to all participants, just before sleeping.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No specific intervention will be provided.
Intervention Type
Other
Intervention Name(s)
Virtual Reality application
Intervention Description
Virtual Reality application with a VR goggle
Primary Outcome Measure Information:
Title
Change in sleep efficiency between experimental and control intervention.
Description
Measured with actigraphy.
Time Frame
Evaluated during two time periods of two weeks.
Title
Change in number of awakenings during the night between experimental and control intervention.
Description
Measured with actigraphy.
Time Frame
Evaluated during two time periods of two weeks.
Secondary Outcome Measure Information:
Title
Change in subjective sleep quality between experimental and control intervention.
Description
Measured with the Pittsburgh Sleep Quality Index (ranging from 0-21 with higher scores a poorer sleep quality).
Time Frame
Evaluated during two time periods of two weeks.
Title
Change in pain intensity reporting between experimental and control intervention.
Description
Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity.
Time Frame
Evaluated during two time periods of two weeks.
Title
Pain catastrophizing
Description
Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing.
Time Frame
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Title
Anxiety and depressive symptoms
Description
Measured with the Hospital Anxiety and Depression Scale
Time Frame
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Title
Change in clinical status
Description
Measured with the Global perceived effect
Time Frame
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Title
Any side effects of the experimental intervention
Time Frame
Evaluated at the end of the experimental intervention namely after the two-week period.
Title
Nature, severity and impact of insomnia
Description
Measured with the Insomnia Severity Index
Time Frame
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 70 years old
Able to speak Dutch/French
Continuing usual care regarding medication use 3 weeks prior and during study participation
Diagnosis of DPN for 6 months or longer, confirmed on EMG
Exclusion Criteria:
History of seizures/epilepsia
Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
shift workers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten Moens, MD PhD
Phone
(+32) 2 477 55 14
Email
maarten.moens@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Goudman
Phone
(+32) 2 477 55 14
Email
lisa.goudman@uzbrussel.be
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten Moens, prof. dr.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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VR in Diabetic Polyneuropathy
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