Diabetic PolyneuropathyNCT04325347
VR in Diabetic Polyneuropathy
A study testing Virtual Reality application in people with Diabetic Polyneuropathy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Virtual Reality application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Jan 2021to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of seizures/epilepsia
- Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
- shift workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From 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.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Virtual Reality application
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality applicationOther
Virtual Reality application with a VR goggle
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Virtual Reality will be provided to all participants, just before sleeping. Receives: Other: Virtual Reality application |
| Control | No intervention | No specific intervention will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep efficiency between experimental and control intervention.
Measured with actigraphy.
Measured: Evaluated during two time periods of two weeks.
Change in number of awakenings during the night between experimental and control intervention.
Measured with actigraphy.
Measured: Evaluated during two time periods of two weeks.
Secondary outcomes (7)
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).
Measured: 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.
Measured: Evaluated during two time periods of two weeks.
Pain catastrophizing
Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing.
Measured: 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
Measured: 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
Measured: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Any side effects of the experimental intervention
Measured: 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
Measured: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start27 Jan 2021
- Primary completion26 Jun 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325347
- Sponsor's protocol ID
- RESOLVE
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT04325347
- Acronym / sponsor ID
- RESOLVE
- Conditions
- Diabetic Polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual Reality applicationVirtual Reality will be provided to all participants, just before sleeping. |
| Control | No intervention | –No specific intervention will be provided. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of seizures/epilepsia
- Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
- shift workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality applicationVirtual Reality application with a VR goggle | Other | Virtual reality |
Primary outcome
Change in sleep efficiency between experimental and control intervention.
Time frame: Evaluated during two time periods of two weeks.
Measured with actigraphy.
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.
7 secondary outcomes
Change in subjective sleep quality between experimental and control intervention.
Time frame: Evaluated during two time periods of two weeks.
Change in pain intensity reporting between experimental and control intervention.
Time frame: Evaluated during two time periods of two weeks.
Pain catastrophizing
Time frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Anxiety and depressive symptoms
Time frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Change in clinical status
Time frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Any side effects of the experimental intervention
Time frame: Evaluated at the end of the experimental intervention namely after the two-week period.
Nature, severity and impact of insomnia
Time frame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality application in people with Diabetic Polyneuropathy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep efficiency between experimental and control intervention. (time frame: Evaluated during two time periods of two weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.