Chronic Low-back PainSleepBackNCT05846087
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
A study testing sleep retraining therapy and sleep health education modules in people with Chronic Low-back Pain and Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Insomnia
- What is being tested?
- sleep retraining therapy and sleep health education modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Sep 2023to 30 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 years.
- Chronic low back pain (pain in lower back region which has been present for 3 months or more).
- Able to give informed online consent.
- Insomnia Severity Index Score >10.
- English fluency.
- Access to a smartphone and willingness/proficiency to use a mobile app for healthcare.
Who cannot join
- Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column.
- Shift-workers. Regular work that falls outside the hours between 7am and 6pm.
- Trans-meridian travel to a destination with >2 hours' time-difference (within last 7-days and will subjective reports that they are not experiencing jet lag).
- Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia).
- Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism).
- Sleep devices (e.g. CPAP)
- Currently receiving psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
- Professional driver or operate heavy machinery;
Trial locations and contacts
1 site in 1 country.
Australia1 site
Woolcock Institute of Medical Research
Sydney, New South Wales, 2037
About this study
Official title: Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study
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).
Read the detailed description
This study is an online, open-labelled, two-arm, parallel-group randomized controlled trial with embedded internal pilot study of dBTi (SleepFix) versus sleep health education control in adults with chronic low back pain (LBP) and insomnia.
To be enrolled in the study, participants are required to complete online pre-screening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study. After interview screening, participants will receive an online baseline questionnaire to complete. Once completed, participants will be randomised to one of two study arms. The treatment arm consists of a dBTi intervention using the SleepFix mobile application. The dBTi intervention takes a minimum of 3 weeks to complete with participants allowed to use SleepFix for longer if they wish. Participants randomized to the control arm will be provide sleep health education through email released weekly during the 3-weeks of intervention treatment. Treatment control participants will receive access to SleepFix once end-of-study questionnaire has been completed.
The study will be conducted online via secure platforms with recruitment primarily through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Glebe, NSW, 2037, Australia.
Phase 1 of the study is an internal pilot study which will assess the feasibility of recruitment, data collection and reporting. The following stop-go progression criteria will be used to determine whether we proceed to phase 2 which will continue recruitment until the sample size is reached (n = 134) to determine our primary outcomes. We will:
- Go if >40% of total sample size (n = 54) are randomized to study arms within 6-months from recruitment start date.
- Stop if >40% of randomized participants fail to complete week 6 end-of-study questionnaires at 6 months from recruitment start date.
Participants who complete the treatment arm of the study will be invited to take part in a post-study interview exploring the user experience of SleepFix and whether it has led to any changes in pain and sleep management. We are conducting these interviews to understand qualitatively how this population feels towards SleepFix and their feelings towards the importance of sleep for their chronic LBP condition.
- Conditions
- Chronic Low-back Pain, Insomnia
- Being tested
- sleep retraining therapy, sleep health education modules
- Keywords
- low back pain, insomnia, digital behavioral therapy for insomnia, sleep retraining therapy, pain interference
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep retraining therapyBehavioural
Also called sleep restriction therapy, sleep consolidation therapy
Sleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed.
sleep health education modulesOther
educational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Three weeks of sleep retraining therapy - behavioral component of cognitive behavioral therapy for insomnia. This will be self-delivered by participants digitally using the smart phone App 'SleepFix'. Receives: Behavioral: sleep retraining therapy |
| Control | Active comparator | Sleep health education modules delivered each week for three weeks. Modules contain information about sleep and insomnia; how insomnia affects other aspects of life; what activities influence health sleep (sleep hygiene) and information designed to dispel false beliefs about sleep Receives: Other: sleep health education modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Brief Pain Inventory (BPI) - pain interference is a subscale of the BPI consisting of 7 items which assess the extent to which pain interferes with: general activity; mood; walking; work (at home or outside); relationships; sleep; and enjoyment of life. BPI items are reported using an 11-point Likert type scale. (0 = "does not interfere"; 10 = "interferes completely"). Responses are summed to provide a global interference score between 0 and 70.
Measured: 6 weeks
Secondary outcomes (7)
Pain intensity
Brief Pain Inventory (BPI) - pain intensity is a subscale of the BPI which is composed of 4-items which ask a rating for current pain, average pain, worst and least pain over the past 24 hours using an 11-point Likert type scales (0 = "No pain at all"; 10 = "worst pain possible").
Measured: 6 weeks
Insomnia severity index (ISI)
7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. All items are summed with total scores ranging from 0-28.
Measured: 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
19-item self-reported questionnaire which, in this case, assesses sleep quality and disturbances over the previous 2 weeks so only variables across a time-period not including the therapy window are measured. Seven component scores are derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.
Measured: 6 weeks
Pain-related beliefs and attitudes about sleep (PBAS)
The pain-related beliefs and attitudes about sleep questionnaire (PBAS) is a 10-item self-reported measure developed for assessment and treatment of insomnia comorbid with chronic pain. PBAS assesses one's beliefs about the interaction of pain and sleep. Items are measured on an 11-point likert type scale (0 = "strongly disagree"; 10 = "strongly agree").
Measured: 6 weeks
Patient Health Questionnaire-2 (PHQ-2)
The Patient Health Questionnaire-2 is a 2-item self-reported measure of depressive symptoms over the past 2 weeks. Participants are asked to answer questions about the severity of depressive symptoms. Scores for each question (Likert type scale "not at all" = 0 to "nearly every day" = 3) sum to a total score of 0 to 6.
Measured: 6 weeks
General Anxiety Disorder-7 (GAD-7)
The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety by asking how often participants have experienced symptoms in the previous two weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.
Measured: 6 weeks
EuroQol five-dimensional (EQ-5D)
The EuroQol five-dimensional (EQ-5D) is a well-validated, generic instrument for measuring health related quality of life at the time of completion. The self-reported questionnaire is comprised of 2 components including: (1) Health state description - measured in terms of 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and (2) evaluation - where participants are asked to evaluate their overall health using a visual analogue scale. In Part 1, each item is assigned a level (ranging from "indicating no problem"1 - "indicating unable to/extreme problems" - 5) according to the response and this descriptive data is used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Sep 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies 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
- Model description
- open labelled, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woolcock Institute of Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative Research Centre for Alertness, Safety and Productivity, University of Sydney
- Responsible party
- Sponsor
- Investigators
- Christopher J Gordon, A/Prof, Principal investigator, Woolcock Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846087
- Sponsor's protocol ID
- X23-0145
- Acronym
- SleepBack
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The trial investigators will be given access to the cleaned data set. The project data set will be housed online in the study web portal created for the study, and all data will be password protected. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information. Data will not be shared without permission of Principal Investigators. All data available for sharing will be stored on a web-based database located in Australia. After the study, a non-identified dataset may be made available online in a data repository.
Publications
Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.
PubMed 32355743Kelly GA, Blake C, Power CK, O'keeffe D, Fullen BM. The association between chronic low back pain and sleep: a systematic review. Clin J Pain. 2011 Feb;27(2):169-81. doi: 10.1097/AJP.0b013e3181f3bdd5.
PubMed 20842008Bilterys T, Siffain C, De Maeyer I, Van Looveren E, Mairesse O, Nijs J, Meeus M, Ickmans K, Cagnie B, Goubert D, Danneels L, Moens M, Malfliet A. Associates of Insomnia in People with Chronic Spinal Pain: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 19;10(14):3175. doi: 10.3390/jcm10143175.
PubMed 34300341Amiri S, Behnezhad S. Sleep disturbances and back pain : Systematic review and meta-analysis. Neuropsychiatr. 2020 Jun;34(2):74-84. doi: 10.1007/s40211-020-00339-9. Epub 2020 Mar 12.
PubMed 32166629Cheatle MD, Foster S, Pinkett A, Lesneski M, Qu D, Dhingra L. Assessing and Managing Sleep Disturbance in Patients with Chronic Pain. Sleep Med Clin. 2016 Dec;11(4):531-541. doi: 10.1016/j.jsmc.2016.08.004. Epub 2016 Oct 27.
PubMed 28118876Aji M, Glozier N, Bartlett D, Peters D, Calvo RA, Zheng Y, Grunstein R, Gordon C. A feasibility study of a mobile app to treat insomnia. Transl Behav Med. 2021 Mar 16;11(2):604-612. doi: 10.1093/tbm/ibaa019.
PubMed 32227087Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.
PubMed 25454674Howarth A, Quesada J, Silva J, Judycki S, Mills PR. The impact of digital health interventions on health-related outcomes in the workplace: A systematic review. Digit Health. 2018 May 10;4:2055207618770861. doi: 10.1177/2055207618770861. eCollection 2018 Jan-Dec.
PubMed 29942631Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
PubMed 26615572Aji M, Gordon C, Stratton E, Calvo RA, Bartlett D, Grunstein R, Glozier N. Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance: Systematic Review. J Med Internet Res. 2021 Feb 17;23(2):e24607. doi: 10.2196/24607.
PubMed 33595441Mameli S, Pisanu GM, Sardo S, Marchi A, Pili A, Carboni M, Minerba L, Trincas G, Carta MG, Melis MR, Agabio R. Oxytocin nasal spray in fibromyalgic patients. Rheumatol Int. 2014 Aug;34(8):1047-52. doi: 10.1007/s00296-014-2953-y. Epub 2014 Feb 8.
PubMed 24509894Tang NK, Goodchild CE, Sanborn AN, Howard J, Salkovskis PM. Deciphering the temporal link between pain and sleep in a heterogeneous chronic pain patient sample: a multilevel daily process study. Sleep. 2012 May 1;35(5):675-87A. doi: 10.5665/sleep.1830.
PubMed 22547894Roth SH, Fleischmann RM, Burch FX, Dietz F, Bockow B, Rapoport RJ, Rutstein J, Lacouture PG. Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: placebo-controlled trial and long-term evaluation. Arch Intern Med. 2000 Mar 27;160(6):853-60. doi: 10.1001/archinte.160.6.853.
PubMed 10737286Malfliet A, Bilterys T, Van Looveren E, Meeus M, Danneels L, Ickmans K, Cagnie B, Mairesse O, Neu D, Moens M, Goubert D, Kamper SJ, Nijs J. The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial. Braz J Phys Ther. 2019 Jan-Feb;23(1):62-70. doi: 10.1016/j.bjpt.2018.10.007. Epub 2018 Oct 29.
PubMed 30389347Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497.
PubMed 26807536
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study
- ClinicalTrials.gov ID
- NCT05846087
- Acronym / sponsor ID
- SleepBack / X23-0145
- Conditions
- Chronic Low-back Pain, Insomnia
- Keywords
- low back pain, insomnia, digital behavioral therapy for insomnia, sleep retraining therapy, pain interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Woolcock Institute of Medical ResearchUniversity, hospital or other
- Collaborators
- Cooperative Research Centre for Alertness, Safety and Productivity, University of Sydney
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 6 May 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 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).
Detailed description
This study is an online, open-labelled, two-arm, parallel-group randomized controlled trial with embedded internal pilot study of dBTi (SleepFix) versus sleep health education control in adults with chronic low back pain (LBP) and insomnia.
To be enrolled in the study, participants are required to complete online pre-screening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study. After interview screening, participants will receive an online baseline questionnaire to complete. Once completed, participants will be randomised to one of two study arms. The treatment arm consists of a dBTi intervention using the SleepFix mobile application. The dBTi intervention takes a minimum of 3 weeks to complete with participants allowed to use SleepFix for longer if they wish. Participants randomized to the control arm will be provide sleep health education through email released weekly during the 3-weeks of intervention treatment. Treatment control participants will receive access to SleepFix once end-of-study questionnaire has been completed.
The study will be conducted online via secure platforms with recruitment primarily through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Glebe, NSW, 2037, Australia.
Phase 1 of the study is an internal pilot study which will assess the feasibility of recruitment, data collection and reporting. The following stop-go progression criteria will be used to determine whether we proceed to phase 2 which will continue recruitment until the sample size is reached (n = 134) to determine our primary outcomes. We will:
- Go if >40% of total sample size (n = 54) are randomized to study arms within 6-months from recruitment start date.
- Stop if >40% of randomized participants fail to complete week 6 end-of-study questionnaires at 6 months from recruitment start date.
Participants who complete the treatment arm of the study will be invited to take part in a post-study interview exploring the user experience of SleepFix and whether it has led to any changes in pain and sleep management. We are conducting these interviews to understand qualitatively how this population feels towards SleepFix and their feelings towards the importance of sleep for their chronic LBP condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- open labelled, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: sleep retraining therapyThree weeks of sleep retraining therapy - behavioral component of cognitive behavioral therapy for insomnia. This will be self-delivered by participants digitally using the smart phone App 'SleepFix'. |
| Control | Active comparator | Other: sleep health education modulesSleep health education modules delivered each week for three weeks. Modules contain information about sleep and insomnia; how insomnia affects other aspects of life; what activities influence health sleep (sleep hygiene) and information designed to dispel false beliefs about sleep |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥ 18 years.
- Chronic low back pain (pain in lower back region which has been present for 3 months or more).
- Able to give informed online consent.
- Insomnia Severity Index Score >10.
- English fluency.
Key exclusion criteria (8 listed)
- Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column.
- Shift-workers. Regular work that falls outside the hours between 7am and 6pm.
- Trans-meridian travel to a destination with >2 hours' time-difference (within last 7-days and will subjective reports that they are not experiencing jet lag).
- Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia).
- Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism).
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 |
|---|---|---|
| sleep retraining therapyAlso: sleep restriction therapy, sleep consolidation therapySleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed. | Behavioural | Treatment |
| sleep health education moduleseducational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks. | Other | Control |
Primary outcome
Pain interference
Time frame: 6 weeks
Brief Pain Inventory (BPI) - pain interference is a subscale of the BPI consisting of 7 items which assess the extent to which pain interferes with: general activity; mood; walking; work (at home or outside); relationships; sleep; and enjoyment of life. BPI items are reported using an 11-point Likert type scale. (0 = "does not interfere"; 10 = "interferes completely"). Responses are summed to provide a global interference score between 0 and 70.
7 secondary outcomes
Pain intensity
Time frame: 6 weeks
Insomnia severity index (ISI)
Time frame: 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks
Pain-related beliefs and attitudes about sleep (PBAS)
Time frame: 6 weeks
Patient Health Questionnaire-2 (PHQ-2)
Time frame: 6 weeks
General Anxiety Disorder-7 (GAD-7)
Time frame: 6 weeks
EuroQol five-dimensional (EQ-5D)
Time frame: 6 weeks
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 2 Dec 2025.
- Background: PubMed 32355743Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.
- Background: PubMed 20842008Kelly GA, Blake C, Power CK, O'keeffe D, Fullen BM. The association between chronic low back pain and sleep: a systematic review. Clin J Pain. 2011 Feb;27(2):169-81. doi: 10.1097/AJP.0b013e3181f3bdd5.
- Background: PubMed 34300341Bilterys T, Siffain C, De Maeyer I, Van Looveren E, Mairesse O, Nijs J, Meeus M, Ickmans K, Cagnie B, Goubert D, Danneels L, Moens M, Malfliet A. Associates of Insomnia in People with Chronic Spinal Pain: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 19;10(14):3175. doi: 10.3390/jcm10143175.
- Background: PubMed 32166629Amiri S, Behnezhad S. Sleep disturbances and back pain : Systematic review and meta-analysis. Neuropsychiatr. 2020 Jun;34(2):74-84. doi: 10.1007/s40211-020-00339-9. Epub 2020 Mar 12.
- Background: PubMed 28118876Cheatle MD, Foster S, Pinkett A, Lesneski M, Qu D, Dhingra L. Assessing and Managing Sleep Disturbance in Patients with Chronic Pain. Sleep Med Clin. 2016 Dec;11(4):531-541. doi: 10.1016/j.jsmc.2016.08.004. Epub 2016 Oct 27.
- Background: PubMed 32227087Aji M, Glozier N, Bartlett D, Peters D, Calvo RA, Zheng Y, Grunstein R, Gordon C. A feasibility study of a mobile app to treat insomnia. Transl Behav Med. 2021 Mar 16;11(2):604-612. doi: 10.1093/tbm/ibaa019.
- Background: PubMed 25454674Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.
- Background: PubMed 29942631Howarth A, Quesada J, Silva J, Judycki S, Mills PR. The impact of digital health interventions on health-related outcomes in the workplace: A systematic review. Digit Health. 2018 May 10;4:2055207618770861. doi: 10.1177/2055207618770861. eCollection 2018 Jan-Dec.
- Background: PubMed 26615572Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
- Background: PubMed 33595441Aji M, Gordon C, Stratton E, Calvo RA, Bartlett D, Grunstein R, Glozier N. Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance: Systematic Review. J Med Internet Res. 2021 Feb 17;23(2):e24607. doi: 10.2196/24607.
- Background: PubMed 24509894Mameli S, Pisanu GM, Sardo S, Marchi A, Pili A, Carboni M, Minerba L, Trincas G, Carta MG, Melis MR, Agabio R. Oxytocin nasal spray in fibromyalgic patients. Rheumatol Int. 2014 Aug;34(8):1047-52. doi: 10.1007/s00296-014-2953-y. Epub 2014 Feb 8.
- Background: PubMed 22547894Tang NK, Goodchild CE, Sanborn AN, Howard J, Salkovskis PM. Deciphering the temporal link between pain and sleep in a heterogeneous chronic pain patient sample: a multilevel daily process study. Sleep. 2012 May 1;35(5):675-87A. doi: 10.5665/sleep.1830.
- Individual participant dataSharing planned: No. The trial investigators will be given access to the cleaned data set. The project data set will be housed online in the study web portal created for the study, and all data will be password protected. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information. Data will not be shared without permission of Principal Investigators. All data available for sharing will be stored on a web-based database located in Australia. After the study, a non-identified dataset may be made available online in a data repository.
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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.
Christopher J Gordon, A/Prof principal investigator
Woolcock Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep retraining therapy and sleep health education modules in people with Chronic Low-back Pain and Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
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 6 inclusion and 8 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 2 Dec 2025. 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 Australia. 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?
Pain interference (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846087, which also lists 24 linked publications.
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 2 Dec 2025.