Chronic InsomniaNCT05618002
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
An observational study of Chronic Insomnia and Chronic Pain, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial summary
Prospective observational crossover study of 250 adults undergoing chronic pain management. For insomnia treatment, patients alternate their usual prescribed sedative versus Lemborexant or Clonidine; on alternate nights. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Chronic Insomnia, Chronic Pain, Restless Leg Syndrome (RLS)
- What is being tested?
- Lemborexant
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2023to 28 Jun 2027
- Phase
- Observational
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult chronic pain clinic patients who have severe chronic insomnia; and undergoing medication treatment for insomnia.
Who may be able to join
- adult chronic pain patients
- good treatment compliance
- severe chronic insomnia
- failure of non-pharmacologic sleep therapy
- regular night sedative therapy for 3 months or more
- regular sleep diary
Show all 9Show fewer
- regular pain and mood diary
- informed consent for diary review
- consent for clinical record quality assurance review
Who cannot join
- obstructive sleep apnoea
- body mass index (BMI) ≥40
- organ insufficiency
- cognitive disorder
- inability to provide consent
- major neuropsychiatric disorder
Show all 19Show fewer
- unreliable diary
- cannabis use
- regular alcohol intake
- stimulant use
- substance abuse
- poor treatment compliance
- high dose opioid
- gabapentinoid use
- other sedative use
- mild insomina
- irregular sedative intake
- regular sedative therapy for less than 3 months
- previous adverse/allergic reactions to clonidine or zopiclone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, V3S 7J1
Olu Bamgbade, MD, CPI, FRCPC, PMP, DBA, +17786286600, salem.painclinic@gmail.com
About this study
Official title: Lemborexant vs Clonidine vs Zopiclone vs Other Sedatives for Managing Chronic Insomnia in Chronic Pain Patients
Prospective observational crossover study of 250 adults undergoing chronic pain management. For insomnia treatment, patients alternate their usual prescribed sedative versus Lemborexant or Clonidine; on alternate nights. Patients use a validated smartwatch and a validated sleep diary to collect data including mood score, sleep score, sleep duration, and adverse effects. Patients complete the diary for 20-25 days. Pain and mood are measured using numeric rating scales. Sleep score is measured using the Likert sleep scale. Within-patient differences are analyzed. Any change in pain, mood, or sleep scores by 2-points is considered significant.
Read the detailed description
Objectives: Chronic pain is associated with insomnia. The first-line therapy for insomnia is cognitive behavioral therapy (CBT-I). The objective of this clinical study is to compare the safety and efficacy of patients' usual night sedatives against Lemborexant or Clonidine. It explores the management of chronic insomnia in patients with chronic pain.
Methods: Prospective observational crossover study of 250 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient takes their usual night sedatives like Zopiclone on alternate nights; alternating with Lemborexant or Clonidine on alternate nights. Each patient's usual night sedative serves as the control or reference. Each patient uses a special validated sleep diary to collect data including pain score, mood score, sleep score, sleep duration, sleep disruptions, sedative type, and adverse effects. Each patient completes the diary for 20-25 days. Pain and mood are measured using the numeric rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain, mood, or sleep scores by 2-points is considered significant. Each patient's usual night sedative serves as the control or reference. Within-patient differences are analysed using 2-sided paired-difference t-test to calculate mean difference and 95% CI. P-value <0.05 is considered significant.
- Conditions
- Chronic Insomnia, Chronic Pain, Restless Leg Syndrome (RLS), Substance Abuse, Tremor, Vasomotor Symptoms; Hot Flashes
- Being tested
- Lemborexant
- Keywords
- Sedative, Hypnotic, Dual orexin receptor antagonist, Insomnia, CBT-I, Lemborexant, Clonidine, Doxepin, Zopiclone, Cannabinoid
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain, Restless Legs Syndrome, Substance-Related Disorders, Tremor, Hot Flashes, Tinnitus, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Also called Zopiclone, Clonidine
For insomnia treatment, each patient takes their usual sedative on alternate nights versus Lemborexant or Clonidine; on alternate nights. Each patient uses a special validated sleep diary to collect data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality score, objective measurement using the validated Likert sleep scale
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
Measured: 3 weeks
Secondary outcomes (2)
Nocturnal pain score, objective measurement using the validated Numeric Pain Rating scale
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
Measured: 3 weeks
Night mood score, objective measurement using the validated Numeric Mood Rating scale
Mood score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less mood, high scores indicate worse mood
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start2 Jan 2023
- Primary completion28 Jun 2027 (estimated)
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olu Bamgbade, MD, CPI, FRCPC, PMP, DBA, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618002
- Sponsor's protocol ID
- SalemSleep2026 LembClonZopDox
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, Murphy-Akpieyi O, Fadire A, Soni NK, Mumporeze L. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients. J Clin Sleep Med. 2022 Jun 1;18(6):1565-1571. doi: 10.5664/jcsm.9930.
PubMed 35112665
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lemborexant vs Clonidine vs Zopiclone vs Other Sedatives for Managing Chronic Insomnia in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT05618002
- Acronym / sponsor ID
- SalemSleep2026 LembClonZopDox
- Conditions
- Chronic Insomnia, Chronic Pain, Restless Leg Syndrome (RLS), Substance Abuse, Tremor, Vasomotor Symptoms; Hot Flashes
- Keywords
- Sedative, Hypnotic, Dual orexin receptor antagonist, Insomnia, CBT-I, Lemborexant, Clonidine, Doxepin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 16 Nov 2022 (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.
Prospective observational crossover study of 250 adults undergoing chronic pain management. For insomnia treatment, patients alternate their usual prescribed sedative versus Lemborexant or Clonidine; on alternate nights. Patients use a validated smartwatch and a validated sleep diary to collect data including mood score, sleep score, sleep duration, and adverse effects. Patients complete the diary for 20-25 days. Pain and mood are measured using numeric rating scales. Sleep score is measured using the Likert sleep scale. Within-patient differences are analyzed. Any change in pain, mood, or sleep scores by 2-points is considered significant.
Detailed description
Objectives: Chronic pain is associated with insomnia. The first-line therapy for insomnia is cognitive behavioral therapy (CBT-I). The objective of this clinical study is to compare the safety and efficacy of patients' usual night sedatives against Lemborexant or Clonidine. It explores the management of chronic insomnia in patients with chronic pain.
Methods: Prospective observational crossover study of 250 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient takes their usual night sedatives like Zopiclone on alternate nights; alternating with Lemborexant or Clonidine on alternate nights. Each patient's usual night sedative serves as the control or reference. Each patient uses a special validated sleep diary to collect data including pain score, mood score, sleep score, sleep duration, sleep disruptions, sedative type, and adverse effects. Each patient completes the diary for 20-25 days. Pain and mood are measured using the numeric rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain, mood, or sleep scores by 2-points is considered significant. Each patient's usual night sedative serves as the control or reference. Within-patient differences are analysed using 2-sided paired-difference t-test to calculate mean difference and 95% CI. P-value <0.05 is considered significant.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult chronic pain clinic patients who have severe chronic insomnia; and undergoing medication treatment for insomnia.
Key inclusion criteria (9 listed)
- adult chronic pain patients
- good treatment compliance
- severe chronic insomnia
- failure of non-pharmacologic sleep therapy
- regular night sedative therapy for 3 months or more
Key exclusion criteria (19 listed)
- obstructive sleep apnoea
- body mass index (BMI) ≥40
- organ insufficiency
- cognitive disorder
- inability to provide consent
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 |
|---|---|---|
| LemborexantAlso: Zopiclone, ClonidineFor insomnia treatment, each patient takes their usual sedative on alternate nights versus Lemborexant or Clonidine; on alternate nights. Each patient uses a special validated sleep diary to collect data. | Drug | – |
Primary outcome
Sleep quality score, objective measurement using the validated Likert sleep scale
Time frame: 3 weeks
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
2 secondary outcomes
Nocturnal pain score, objective measurement using the validated Numeric Pain Rating scale
Time frame: 3 weeks
Night mood score, objective measurement using the validated Numeric Mood Rating scale
Time frame: 3 weeks
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 2 Nov 2026.
- Results publication: PubMed 35112665Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, Murphy-Akpieyi O, Fadire A, Soni NK, Mumporeze L. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients. J Clin Sleep Med. 2022 Jun 1;18(6):1565-1571. doi: 10.5664/jcsm.9930.
- Individual participant dataSharing planned: No
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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.
Olu Bamgbade, MD, CPI, FRCPC, PMP, DBA principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Insomnia and Chronic Pain, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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 9 inclusion and 19 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 2 Nov 2026. 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 Canada. 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 Olu Bamgbade, MD, CPI, FRCPC, PMP, DBA (+17786286600, salem.painclinic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality score, objective measurement using the validated Likert sleep scale (time frame: 3 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 NCT05618002, which also lists 1 linked publication.
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 Nov 2026.