Neuropathic PainNCT06155916
Sleep and Neuropathic Pain - Intervention Study on Pregabalin
A study testing Pregabalin in people with Neuropathic Pain and Insomnia, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain, Insomnia, Sleep Disorder
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFinland
- Study dates
- 22 Nov 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic (duration > 3 months) painful peripheral neuropathy
- Pain moderate to severe (NRS ≥ 4/10) during the past week
Who cannot join
- psychotic depression, clinically significant bipolar disorder
- contraindication for performing brain fMRI (metal in the body etc)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, HUS, 00029
Hanna T Harno, MD, PhD, +358503427375, hanna.harno@hus.fi
Eija Kalso, MD, PhD
- Recruiting
Helsinki University Hospital, Department of Neurology
Helsinki, Uusimaa, 00029
Hanna Harno, PhD, +358503427375, hanna.harno@hus.fi
About this study
Official title: Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are:
- Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance?
- Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will
- Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention
- Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI.
Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.
Read the detailed description
This is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration>3 months) moderate to severe pain (NRS ≥ 4/10) due to peripheral neuropathy. The investigators divide patients to two groups according to scores in ISI: the ones with clinically significant insomnia with score 15 or more (ISI High) and the ones without marked insomnia with score 14 or lower (ISI Low). Sleep will be assessed by a sleep diary, iButton, polysomnography and 1-week Actiwatch monitoring before and after 1-month stabile pregabalin dosage. Additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain MRI will be performed. At pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. After a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fMRI are repeated. The study duration is about 3 months.
- Conditions
- Neuropathic Pain, Insomnia, Sleep Disorder
- Being tested
- Pregabalin
- Keywords
- polysomnography, actigraphy, fMRI, pregabalin, neuropathic pain
- Medical subject headings
- Neuralgia, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Pregabalin for high insomnia patients with painful neuropathy, Pregabalin for low insomnia patients with painful neuropathy
Pregabalin administration and titration to the highest dosage that the patient tolerates. The patient continues with the highest dose for one month and the pre-intervention studies are repeated.
| Study group | Role | What they receive |
|---|---|---|
| High ISI | Experimental | Patients that have clinically significant insomnia according to ISI questionnaire (score 15 or more) at baseline. Receives: Drug: Pregabalin |
| Low ISI | Experimental | Patients with no clinically significant insomnia according to ISI questionnaire (score 14 or less) at baseline. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregabalin response to pain
Pain intensity and interference assessed by numeric rating scale
Measured: Change from baseline pain intensity and interference immediately after the intervention
Pregabalin effect on sleep stages
1-night Ambulatory Polysomnography (NREM stage III)
Measured: Change from baseline immediately after the intervention
Sleep disturbance associations to brain network connectivity
Brain fMRI for brain network connectivity
Measured: Change from baseline immediately after the intervention
Sleep disturbance associations to choroid plexus volume in brain fMRI
Brain fMRI for choroid plexus volume measures
Measured: Change from baseline immediately after the intervention
Pregabalin effect on circadian rhythms
1-week actigraphy
Measured: Change from baseline immediately after the intervention
Pregabalin effect on body temperature during sleep
1-night body temperature measurement by iButton
Measured: Change from baseline immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start22 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients start with pregabalin at dose 25mg-75mg per day according to their preference and dose will be added by 25mg to 75 mg/ 4 days up to the highest dosage the patient tolerates (maximum 300mg twice daily). After having pregabalin stabile for one month with the highest tolerated dosage, post-examinations are repeated while still using pregabalin.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Hanna Harno, Helsinki University Central Hospital
- Investigators
- Hanna Harno, PhD, Study chair, Helsinki University Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155916
- Sponsor's protocol ID
- TYH2020214
- Status last verified
- Mar 2025
- First submitted
- 29 May 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
- ClinicalTrials.gov ID
- NCT06155916
- Acronym / sponsor ID
- TYH2020214
- Conditions
- Neuropathic Pain, Insomnia, Sleep Disorder
- Keywords
- polysomnography, actigraphy, fMRI, pregabalin, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Dec 2023 (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.
The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are:
- Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance?
- Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will
- Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention
- Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI.
Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.
Detailed description
This is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration>3 months) moderate to severe pain (NRS ≥ 4/10) due to peripheral neuropathy. The investigators divide patients to two groups according to scores in ISI: the ones with clinically significant insomnia with score 15 or more (ISI High) and the ones without marked insomnia with score 14 or lower (ISI Low). Sleep will be assessed by a sleep diary, iButton, polysomnography and 1-week Actiwatch monitoring before and after 1-month stabile pregabalin dosage. Additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain MRI will be performed. At pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. After a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fMRI are repeated. The study duration is about 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients start with pregabalin at dose 25mg-75mg per day according to their preference and dose will be added by 25mg to 75 mg/ 4 days up to the highest dosage the patient tolerates (maximum 300mg twice daily). After having pregabalin stabile for one month with the highest tolerated dosage, post-examinations are repeated while still using pregabalin.
| Arm | Type | Receives |
|---|---|---|
| High ISI | Experimental | Drug: PregabalinPatients that have clinically significant insomnia according to ISI questionnaire (score 15 or more) at baseline. |
| Low ISI | Experimental | Drug: PregabalinPatients with no clinically significant insomnia according to ISI questionnaire (score 14 or less) at baseline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic (duration > 3 months) painful peripheral neuropathy
- Pain moderate to severe (NRS ≥ 4/10) during the past week
Key exclusion criteria (2 listed)
- psychotic depression, clinically significant bipolar disorder
- contraindication for performing brain fMRI (metal in the body etc)
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 |
|---|---|---|
| PregabalinAlso: Pregabalin for high insomnia patients with painful neuropathy, Pregabalin for low insomnia patients with painful neuropathyPregabalin administration and titration to the highest dosage that the patient tolerates. The patient continues with the highest dose for one month and the pre-intervention studies are repeated. | Drug | High ISI, Low ISI |
Primary outcome
Pregabalin response to pain
Time frame: Change from baseline pain intensity and interference immediately after the intervention
Pain intensity and interference assessed by numeric rating scale
Pregabalin effect on sleep stages
Time frame: Change from baseline immediately after the intervention
1-night Ambulatory Polysomnography (NREM stage III)
Sleep disturbance associations to brain network connectivity
Time frame: Change from baseline immediately after the intervention
Brain fMRI for brain network connectivity
Sleep disturbance associations to choroid plexus volume in brain fMRI
Time frame: Change from baseline immediately after the intervention
Brain fMRI for choroid plexus volume measures
Pregabalin effect on circadian rhythms
Time frame: Change from baseline immediately after the intervention
1-week actigraphy
Pregabalin effect on body temperature during sleep
Time frame: Change from baseline immediately after the intervention
1-night body temperature measurement by iButton
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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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.
Hanna Harno, PhD study chair
Helsinki University Hospital, Department of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with Neuropathic Pain and Insomnia, run by Helsinki University Central Hospital at 2 sites in Finland.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Harno, PhD (+358503427375, hanna.harno@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregabalin response to pain (time frame: Change from baseline pain intensity and interference immediately after the intervention). The study lists 6 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 14 Mar 2025.