VR in Diabetic Polyneuropathy

Diabetic Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325347
• Other study ID #: RESOLVE
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: July 24, 2023

Study information

• Verified date: June 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 24, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Other:
• Virtual Reality application
Virtual Reality application with a VR goggle

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep efficiency between experimental and control intervention.	Measured with actigraphy.	Evaluated during two time periods of two weeks.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Any side effects of the experimental intervention		Evaluated at the end of the experimental intervention namely after the two-week period.
Secondary	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.