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Completed

NCT Number: NCT04325347

VR in Diabetic Polyneuropathy

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.

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Application

Other

Virtual Reality application with a VR goggle

Primary outcomes

  1. Change in sleep efficiency between experimental and control intervention.

    Time frame: 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.

    Time frame: Evaluated during two time periods of two weeks.

    Measured with actigraphy.

Secondary outcomes

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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Evaluated at the end of the experimental intervention namely after the two-week period.

  7. Nature, severity and impact of insomnia

    Time frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.

    Measured with the Insomnia Severity Index

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2020
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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