VR in Diabetic Polyneuropathy

June 11, 2024 updated by: Moens Maarten, Universitair Ziekenhuis Brussel

Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Jette, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
Virtual Reality will be provided to all participants, just before sleeping.
Other: Virtual Reality application
Virtual Reality application with a VR goggle
No Intervention: Control
No specific intervention will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep efficiency between experimental and control intervention.
Time Frame: Evaluated during two time periods of two weeks.
Measured with actigraphy.
Evaluated during two time periods of two weeks.
Change in number of awakenings during the night between experimental and control intervention.
Time Frame: Evaluated during two time periods of two weeks.
Measured with actigraphy.
Evaluated during two time periods of two weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective sleep quality between experimental and control intervention.
Time Frame: Evaluated during two time periods of two weeks.
Measured with the Pittsburgh Sleep Quality Index (ranging from 0-21 with higher scores a poorer sleep quality).
Evaluated during two time periods of two weeks.
Change in pain intensity reporting between experimental and control intervention.
Time Frame: Evaluated during two time periods of two weeks.
Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity.
Evaluated during two time periods of two weeks.
Pain catastrophizing
Time Frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing.
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Anxiety and depressive symptoms
Time Frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Measured with the Hospital Anxiety and Depression Scale
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Change in clinical status
Time Frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Measured with the Global perceived effect
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Any side effects of the experimental intervention
Time Frame: Evaluated at the end of the experimental intervention namely after the two-week period.
Evaluated at the end of the experimental intervention namely after the two-week period.
Nature, severity and impact of insomnia
Time Frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Measured with the Insomnia Severity Index
Evaluated at the end of the experimental and control intervention namely after the two-week periods.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESOLVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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