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NCT05846087: SleepBack
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
NA trial testing sleep retraining therapy in Chronic Low-back Pain in 106 participants. Completed in 30 October 2025.
30 October 2025
Quick facts
| Lead sponsor | Woolcock Institute of Medical Research |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 13 September 2023 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- sleep retraining therapy
- sleep health education modules
Conditions studied
- Chronic Low-back Pain — all drugs for Chronic Low-back Pain →
- Insomnia — all drugs for Insomnia →
Sponsor
Woolcock Institute of Medical Research
Who can join
18 and older, any sex, with Chronic Low-back Pain or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement. Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
- PubMed search for NCT05846087
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Low-back Pain
Currently open trials in the same condition.
- NCT06891625 — Movement Performance in Persons With Chronic Back Pain · NA · recruiting
- NCT06568198 — Modulation Effect of tACS on Chronic Low Back Pain · Phase 2 · recruiting
- NCT06825390 — AuriculoTherapy NeuroImaging · NA · recruiting
- NCT04824248 — Weight Reduction in CLBP · NA · recruiting
- NCT07055802 — Effects Of Inversion Table Therapy Vs MT On Pain And Lumbar Flexibility In Patients With Chronic Low Back Pain · NA · active not recruiting
Other Woolcock Institute of Medical Research trials
Trials by the same sponsor.
- NCT07405775 — SleepFix for Youth: Digital Behavioural Therapy for Insomnia With E-Psychologist Support · NA · not yet recruiting
- NCT05335083 — CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects · NA · not yet recruiting
- NCT06801379 — A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study · EARLY_PHASE1 · recruiting
- NCT06686667 — The Feasibility of Overnight Time Restricted Eating and Impact on Glucose Levels in Shift Workers · NA · completed
- NCT06114901 — Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05846087 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Woolcock Institute of Medical Research
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05846087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing