VR in Diabetic Polyneuropathy

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04325347
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.1
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Polyneuropathy	Other: Virtual Reality application	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy
• Actual Study Start Date: Jan 27, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in sleep efficiency between experimental and control intervention. [Evaluated during two time periods of two weeks.]

   Measured with actigraphy.

2. Change in number of awakenings during the night between experimental and control intervention. [Evaluated during two time periods of two weeks.]

   Measured with actigraphy.

Secondary Outcome Measures

1. Change in subjective sleep quality between experimental and control intervention. [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).

2. Change in pain intensity reporting between experimental and control intervention. [Evaluated during two time periods of two weeks.]

   Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity.

3. Pain catastrophizing [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.

4. Anxiety and depressive symptoms [Evaluated at the end of the experimental and control intervention namely after the two-week periods.]

   Measured with the Hospital Anxiety and Depression Scale

5. Change in clinical status [Evaluated at the end of the experimental and control intervention namely after the two-week periods.]

   Measured with the Global perceived effect

6. Any side effects of the experimental intervention [Evaluated at the end of the experimental intervention namely after the two-week period.]

7. Nature, severity and impact of insomnia [Evaluated at the end of the experimental and control intervention namely after the two-week periods.]

   Measured with the Insomnia Severity Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Jette		Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moens Maarten, principal investigator, Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT04325347
• Other Study ID Numbers: RESOLVE
• First Posted: Mar 27, 2020
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polyneuropathies; Diabetic Neuropathies

Study Results

No Results Posted as of Jan 29, 2021