VR in Diabetic Polyneuropathy
Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
January 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2023
CompletedJune 12, 2024
June 1, 2024
2.4 years
March 16, 2020
June 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in sleep efficiency between experimental and control intervention.
Measured with actigraphy.
Evaluated during two time periods of two weeks.
Change in number of awakenings during the night between experimental and control intervention.
Measured with actigraphy.
Evaluated during two time periods of two weeks.
Secondary Outcomes (7)
Change in subjective sleep quality between experimental and control intervention.
Evaluated during two time periods of two weeks.
Change in pain intensity reporting between experimental and control intervention.
Evaluated during two time periods of two weeks.
Pain catastrophizing
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Anxiety and depressive symptoms
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Change in clinical status
Evaluated at the end of the experimental and control intervention namely after the two-week periods.
- +2 more secondary outcomes
Study Arms (2)
Virtual reality
EXPERIMENTALVirtual Reality will be provided to all participants, just before sleeping.
Control
NO INTERVENTIONNo specific intervention will be provided.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of seizures/epilepsia
- Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
- shift workers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Jette, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 16, 2020
First Posted
March 27, 2020
Study Start
January 27, 2021
Primary Completion
June 26, 2023
Study Completion
July 24, 2023
Last Updated
June 12, 2024
Record last verified: 2024-06