[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07598734":3,"trial-entities:NCT07598734":118,"trial-summary:NCT07598734":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":51,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":84,"locations":87,"central_contacts":106,"overall_officials":114,"references":116,"see_also_links":117},"NCT07598734","STUDY00024373","Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty","Doxepin Versus Doxepin and Ramelteon Versus Placebo to Improve Sleep Quality After Primary Total Knee Arthroplasty: A Randomized Controlled Trial","NOT_YET_RECRUITING","2028-06","2026-05","2026-05-20","2026-06","University of Washington","OTHER",true,"Many patients experience poor sleep during recovery after total knee arthroplasty (TKA). Disturbed sleep can last weeks to months and may worsen pain, slow healing, and reduce overall quality of life. Few safe, effective, evidence-based options exist to improve sleep during this recovery period. This study aims to determine whether the medications doxepin, either alone or in combination with ramelteon, can improve sleep quality during early recovery after TKA. The investigators will also evaluate whether improved sleep leads to better pain control, knee function, and overall quality of life.","This randomized, placebo-controlled clinical trial seeks to answer the following question: Is doxepin or combination therapy consisting of doxepin plus ramelteon superior to placebo in terms of (1) sleep quality as measured by the Insomnia Severity Index, (2) postoperative knee function as measured by KOOS-JR, KOOS-PS, or (3) overall health-related quality of life during the first three months after total knee arthroplasty.",[19,20,21],"Sleep Quality Post-TKA","Postoperative Knee Function","Quality of Life After Primary TKA",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[26],"PHASE4",{"count":28,"type":29},129,"ESTIMATED",[31,37,41],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Doxepin 6 mg","Doxepin 6 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty",[33,36],"Doxepin 6 mg and Ramelteon 8mg",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Ramelteon 8 mg","Ramelteon 8 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty",[36],{"type":32,"name":42,"description":43,"armGroupLabels":44},"Placebo Tablets","Placebo administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty",[45],"Placebo",[47],{"measure":48,"description":49,"timeFrame":50},"Insomnia Severity Index (ISI) scores (sleep quality)","Insomnia Severity Index (ISI) The Insomnia Severity Index is a 7-item self-reported questionnaire assessing the nature, severity, and impact of insomnia.\n\n* Score range: 0 to 28\n* Interpretation: Higher scores indicate worse insomnia severity\n\nScore categories:\n\n* 0-7: No clinically significant insomnia\n* 8-14: Subthreshold insomnia\n* 15-21: Clinical insomnia (moderate severity)\n* 22-28: Clinical insomnia (severe)","Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively",[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)","Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS):\n\nThe KOOS-PS is a 7-item patient-reported outcome measure assessing knee-related physical function, including activities such as rising from bed, putting on socks, rising from sitting, bending to the floor, twisting\u002Fpivoting, kneeling, and squatting . Each item is scored on a 5-point Likert scale (None to Extreme). Scores are transformed to a normalized scale ranging from 0 to 100, with higher scores indicating worse physical function (greater disability).","Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively.",{"measure":57,"description":58,"timeFrame":50},"Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)","Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR):\n\nThe KOOS-JR is a patient-reported outcome measure assessing knee pain, stiffness, and functional limitations during activities of daily living over the past week, including tasks such as twisting\u002Fpivoting, stair navigation, standing, rising from sitting, and bending . The instrument consists of 7 items scored on a 5-point Likert scale (None to Extreme). Raw scores (range 0-28) are summed and converted to an interval score ranging from 0 to 100, where 0 represents total knee disability and 100 represents perfect knee health (higher scores indicate better outcomes)",{"measure":60,"description":61,"timeFrame":50},"Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)","Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10):\n\nThe PROMIS-10 is a 10-item patient-reported outcome measure assessing global physical health, mental health, pain, fatigue, and social functioning. Items are scored on 5-point Likert scales (e.g., Excellent to Poor; Not at all to Very much), with one pain item scored from 0 to 10. Raw scores are summed and converted to standardized T-scores for Global Physical Health and Global Mental Health, each ranging approximately from 0 to 100 (mean 50, standard deviation 10), where higher scores indicate better health status","ALL","18 Years","80 Years",false,{"inclusion":67,"exclusion":70,"raw_text":83},[68,69],"Those receiving primary total knee arthroplasty (TKA)","80 years or less, age 18 or greater",[71,72,73,74,75,76,77,78,79,80,81,82],"History of cardiovascular bundle branch block","Actively taking selecrtive serotoin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or having treatment via counseling\u002Fpsychotherapy for major depression or anxiety, bipolar, or psychotic disorder","Pre-operative narcotics (defined as more than 1 prescription in the past 3 months)","Self-reported use of alcohol in excess of \\>2 drinks\u002Fday (in men) and \\> 1 drink\u002Fday (in women)","Use of prescription sleep aids (e.g., Ambien, Trazadone) prior to surgery (i.e., melatonin or other OTC sleep aids are permitted)","History of major sleep disorder (e.g., obstructive sleep apnea (OSA), restless leg syndrome, narcolepsy)","Pregnant, breastfeeding or planning to become pregnant in the next 3 months post-surgery. No pregnancy testing will be performed; screening will rely solely on participant self-report.","Unable to take the study medication(s) due to contraindications with other medications the patient uses","Have been diagnosed with (or are at risk of) narrow-angle or angle-closure glaucoma. In order to be eligible, participants must be able to report that they have had their eyes dilated within the past year without problems.","Have severe urinary retention or difficulty emptying your bladder.","Had glaucoma-related eye procedures (e.g., laser iridotomy)","Ongoing use of glaucoma eye drops.","Inclusion Criteria:\n\n* Those receiving primary total knee arthroplasty (TKA)\n* 80 years or less, age 18 or greater\n\nExclusion Criteria:\n\n* History of cardiovascular bundle branch block\n* Actively taking selecrtive serotoin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or having treatment via counseling\u002Fpsychotherapy for major depression or anxiety, bipolar, or psychotic disorder\n* Pre-operative narcotics (defined as more than 1 prescription in the past 3 months)\n* Self-reported use of alcohol in excess of \\>2 drinks\u002Fday (in men) and \\> 1 drink\u002Fday (in women)\n* Use of prescription sleep aids (e.g., Ambien, Trazadone) prior to surgery (i.e., melatonin or other OTC sleep aids are permitted)\n* History of major sleep disorder (e.g., obstructive sleep apnea (OSA), restless leg syndrome, narcolepsy)\n* Pregnant, breastfeeding or planning to become pregnant in the next 3 months post-surgery. No pregnancy testing will be performed; screening will rely solely on participant self-report.\n* Unable to take the study medication(s) due to contraindications with other medications the patient uses\n* Have been diagnosed with (or are at risk of) narrow-angle or angle-closure glaucoma. In order to be eligible, participants must be able to report that they have had their eyes dilated within the past year without problems.\n* Have severe urinary retention or difficulty emptying your bladder.\n* Had glaucoma-related eye procedures (e.g., laser iridotomy)\n* Ongoing use of glaucoma eye drops.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":103},"University of Washington Medical Center Hip & Knee Center","Seattle","Washington","98133","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Portia Morgan","CONTACT","206-668-3674","morganp9@uw.edu",{"name":101,"role":102},"Nicholas M Hernandez, MD","PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},47.60621,-122.33207,[107,111],{"name":108,"role":97,"phone":109,"email":110},"Gerald Y Liao, MS","617-710-7211","liaog@uw.edu",{"name":101,"role":97,"phone":112,"email":113},"530-514-1275","nichern@uw.edu",[115],{"name":101,"affiliation":13,"role":102},[],[],{"nct_id":4,"conditions":119,"biomarkers":122},[120,121],"Insomnia","Total Knee Replacement",[],{"nct_id":4,"found":15,"summary":124,"prompt_version":132},{"design":125,"status":126,"heading":6,"summary":127,"follow_up":125,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"Not specified.","completed","{\n   \"Doxepin and Ramelteon for Sleep After Total Knee Replacement\",\n   \"This study is looking at ways to improve sleep after total knee replacement surgery (TKA). Many people have trouble sleeping during recovery, which can make pain worse and slow healing. This trial will test if the medications doxepin, or doxepin combined with ramelteon, can help you sleep better during the first six weeks after surgery. Researchers will compare these medications to a placebo (an inactive pill). They also want to see if better sleep leads to less pain, better knee function, and an improved quality of life. You may be able to join if you are between 18 and 80 years old and are having a primary total knee replacement.\",\n  \"design\": \"This is a randomized, placebo-controlled study planning to enroll 129 participants. Participants will be assigned by chance to receive doxepin, doxepin combined with ramelteon, or a placebo.\",\n  \"commitments\": \"Participants will take medication nightly for six weeks after surgery. Sleep quality, knee function, and quality of life will be measured at baseline, 2 weeks, 6 weeks, and 3 months post-surgery.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for three months after their total knee replacement surgery.\",\n}",202,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]