VR in Diabetic Polyneuropathy

Study Overview
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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.

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

Conditions
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Diabetic Polyneuropathy

Intervention / Treatment
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* Other: Virtual Reality application


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Evaluated during two time periods of two weeks. | 
| Change in pain intensity reporting between experimental and control intervention. | Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity. | Evaluated during two time periods of two weeks. | 
| Pain catastrophizing | 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 | 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 | 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 |  | Evaluated at the end of the experimental intervention namely after the two-week period. | 
| Nature, severity and impact of insomnia | Measured with the Insomnia Severity Index | Evaluated at the end of the experimental and control intervention namely after the two-week periods. |