Can a sleep app ease chronic pain? new trial investigates
NCT ID NCT06361914
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a digital version of cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and reduce pain in 140 adults with chronic pain and insomnia. Participants will either receive the digital CBT-I program or digital sleep hygiene education. The goal is to find a safe, accessible alternative to sleeping pills for this common combination of conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- digital cognitive behavioral therapy for insomnia (CBT-I)
- What this could lead to
- If it works, this could provide an accessible, non-drug treatment to improve sleep and reduce pain for people with chronic pain and insomnia.
- What could go wrong
- This is a relatively small trial (140 participants) testing a behavioral intervention, so results may not apply to everyone. The digital format may not work as well as in-person therapy for some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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140 people
The number who actually took part.
- Started
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Apr 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For a participant to be eligible, all inclusion criteria must be answered "yes": * Age ≥ 18 years. * Understand and write Danish. * Have smartphone access. * Pain for 3 months or longer. * Pain must be present on 'most days' or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did you have pain? - response options: 'never'; 'some days'; 'most days'; 'every day'). * Pain must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months (will be checked by the question: 'In the past 3 months, how often did your pain limit your life or work activities - response options: never, some days, most days, every day * Average pain intensity equal to or higher than 4 on a 0-10 Numeric Rating Scale \[NRS\] in the past 7 days (ranging from 'no pain' to 'worst imaginable pain'). Insomnia symptoms (Insomnia Severity Index (ISI) score \> 10; moderate insomnia). Exclusion Criteria: For a participant to be eligible, all exclusion criteria must be answered "no": * Pregnancy or lactation (Pregnancy is screened for through self-reporting as no risks regarding pregnancy have been identified for the described study procedures). * Does not have daily assess to smartphone/tablet * Night shift during the time of the CBT-I treatment. * Currently receiving pharmacological treatment for insomnia (e.g. benzodiazepines, hypnotics etc.). * Severe psychiatric/somatic illnesses of relevance of their sleep (reported by participant). * Diagnosed sleep disorders (e.g., OSA, narcolepsy). * Does not have E-boks. * Known abuse of alcohol or other substances. * Suicide and self-harm thoughts (reported by participant). * People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation. For the EEG subgroup only (60 patients): * Age ≥ 65 years * Anatomy of the outer ear making it impossible to do ear EEG monitoring. * Ear piercings that are not compatible with ear EEG. * Previous stroke or cerebral haemorrhage and any other structural cerebral disease. * Teeth grinding (bruxism). * Allergic contact dermatitis caused by metals or generally prone to skin irritation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense
Odense, 5000, Denmark
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