VR in Diabetic Polyneuropathy

NCT ID: NCT04325347

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2023-07-24

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Virtual reality

Virtual Reality will be provided to all participants, just before sleeping.

Group Type EXPERIMENTAL

Virtual Reality application

Intervention Type OTHER

Virtual Reality application with a VR goggle

Control

No specific intervention will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality application

Virtual Reality application with a VR goggle

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Moens Maarten

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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RESOLVE

Identifier Type: -

Identifier Source: org_study_id

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