Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT05618002
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2022-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634104', 'term': 'lemborexant'}, {'id': 'C515050', 'term': 'zopiclone'}, {'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality score, objective measurement using the validated Likert sleep scale', 'timeFrame': '3 weeks', 'description': 'Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep'}], 'secondaryOutcomes': [{'measure': 'Pain score, objective measurement using the validated Numeric Pain Rating scale', 'timeFrame': '3 weeks', 'description': 'Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedative', 'Hypnotic'], 'conditions': ['Chronic Insomnia', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '35112665', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.', 'detailedDescription': "Objectives: Chronic pain is usually associated with insomnia. The objective of this clinical study is to compare the safety and efficacy of Lemborexant or Zopiclone or Clonidine; for the management of chronic insomnia in patients with chronic pain.\n\nMethods: Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \\<0.05 is considered significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult chronic pain clinic patients who have severe chronic insomnia; and undergoing medication treatment for insomnia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult chronic pain patients\n* good treatment compliance\n* severe chronic insomnia\n* failure of non-pharmacologic sleep therapy\n* regular zopiclone therapy for 3 months or more\n* regular sleep diary\n* regular pain diary\n* informed consent for diary review\n* consent for clinical record quality assurance review\n\nExclusion Criteria:\n\n* obstructive sleep apnoea\n* body mass index (BMI) ≥40\n* organ insufficiency\n* cognitive disorder\n* inability to provide consent\n* major neuropsychiatric disorder\n* unreliable diary\n* cannabis use\n* regular alcohol intake\n* stimulant use\n* substance abuse\n* poor treatment compliance\n* high dose opioid\n* gabapentinoid use\n* sedative use\n* mild insomina\n* irregular zopiclone intake\n* regular zopiclone therapy for less than 3 months\n* previous adverse/allergic reactions to clonidine or zopiclone'}, 'identificationModule': {'nctId': 'NCT05618002', 'briefTitle': 'Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Salem Anaesthesia Pain Clinic'}, 'officialTitle': 'Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients', 'orgStudyIdInfo': {'id': 'SalemAnaesth2022 LemborexZop'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lemborexant', 'type': 'DRUG', 'otherNames': ['Zopiclone', 'Clonidine'], 'description': 'For insomnia treatment, each patient ingests Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3S 7J1', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '+17786286600'}], 'facility': 'Salem Anaesthesia Pain Clinic', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}], 'centralContacts': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '+17786286600'}], 'overallOfficials': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salem Anaesthesia Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Anaesthesia Pain Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}