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Promoting Sleep to Alleviate Pain - Arthroplasty

Study acronym: PROSAP-A
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion date: Dec 2030 to Dec 1, 2030v5
  2. Secondary endpoints: details revised at 2 of 14 entriesv4
  3. Primary completion date: Jan 2029 to Dec 1, 2029v3 Show 6 more changesShow less
    • Start date: Oct 1, 2024 to Sep 1, 2025
    • Primary endpoints: 2 to 1
    • Study completion date: Jan 2030 to Dec 2030
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 17 to 14
    • Site contact updated
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 9 more changesShow less
    • Primary completion date: Jan 2028 to Jan 2029
    • Start date changed from estimate of Jan 2024 to Oct 1, 2024
    • Primary endpoints: 3 to 2
    • Study sites: 0 to 1
    • Study completion date: Jan 2028 to Jan 2030
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 15 to 17
    • Collaborators shortened, about 15 words
    • Study description expanded, about 1 word
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.
Trial Details
NCT Number NCT06145516
Lead Sponsor Uppsala University
Conditions
(from sponsor)		 Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery, Pain, Postoperative, Postoperative Complications
Related terms Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee, Parasomnias, Postoperative Complications, Postoperative Pain, Sleep Initiation and Maintenance Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov