Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study (NCT07008924) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study
United States50 participantsStarted 2022-07-14
Plain-language summary
Our goal is to observational study is to determine feasibility of partial sleep restriction in individuals with CLBP+I and correlation findings with features of central sensitization.
* Identify feasibility of sleep restriction protocol
* Identify correlation between less sleep and central sensitization Sleep will be monitored for 2 weeks (baseline sleep monitoring period). Then participants will be asked to restrict their sleep to 80% of their normal sleep duration for 5 nights (sleep restriction period). Then sleep will be monitored again for 2 weeks (sleep recovery period).
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
• 25-65 years old individuals
Additional inclusion criteria for individuals with CLBP+I:
* With or without insomnia
* CLBP (LBP for at least 3 months with or without referred or radiating leg pain; pain intensity 1 or greater on 0 - 10 VAS scale
* likely to participate in all scheduled evaluations and study procedures by self-report
* agrees to abide by safely protocol e.g. not to drive or operate heavy machinery and perform heavy labor work, during the sleep-restriction period
Exclusion Criteria:
* spine compression, tumor, infection, history of spine surgery
* neurological conditions such as stroke, Parkinson's disease, Alzheimer's disease or other cognitive impairments.
* pregnancy
* known untreated sleep disorder (such as current sleep apnea or current restless leg syndrome) screened by the following scales to ensure insomnia symptoms are due to insomnia and not another common sleep disorders:
* Those with increased risk of sleep apnea
* Increased risk of restless leg syndrome on RLS-Diagnosis Index
* Increased risk of circadian rhythm sleep-wake disorder
* Increased risk of parasomnia
* Moderate level of depression identified by Patient Health Questionnaire (PHQ-9)
* Moderate level of anxiety identify by Generalized Anxiety Disorder (GAD-7)
* history of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
* severe mental illness such as schizophrenia or bipolar disorder
* developmental history of learning disability or atte…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep Measures
Timeframe: Through study completion, up to 5 weeks
2
Sleep Measures
Timeframe: Through study completion, up to 5 weeks
3
Sleep Measures
Timeframe: Through study completion, up to 5 weeks
4
Pain Measures
Timeframe: Through study completion, up to 5 weeks
5
Pain Measures
Timeframe: Through study completion, up to 5 weeks