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Sleep Hygiene Education for Hip Replacement Surgery

Phase 4
Waitlist Available
Led By James A Keeney, MD
Research Sponsored by James A. Keeney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post-op
Awards & highlights

Study Summary

This trial compares sleep aids to sleep education in order to improve postoperative sleep quality.

Eligible Conditions
  • Hip Replacement Surgery
  • Total Knee Replacement

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epworth Sleepiness Scale (ESS)
Pittsburgh Sleep Quality Index (PSQI)
Visual Analogue Scale (VAS) for pain

Trial Design

3Treatment groups
Active Control
Group I: Control group (Usual Care)Active Control1 Intervention
Usual care
Group II: Sleep Hygiene EducationActive Control1 Intervention
Sleep Hygiene Education
Group III: Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)Active Control3 Interventions
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) and Sleep Hygiene Education

Find a Location

Who is running the clinical trial?

James A. KeeneyLead Sponsor
James A Keeney, MDPrincipal InvestigatorUniversity of Missouri Health System, Department of Orthopaedic Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies can be remedied by Sleep Hygiene Education?

"Sleep Hygiene Education is a form of treatment typically applied to patients with angioedema, yet it can be beneficial for those afflicted by bronchitis and delayed hypersensitivity as well. Additionally, this approach may help individuals dealing with eye-related conditions."

Answered by AI

Could you elaborate on the prior experimentation surrounding Sleep Hygiene Education?

"Currently, there are 55 separate studies centered around Sleep Hygiene Education being conducted. 12 of these trials have reached the final stage - Phase 3. Most of these research efforts are taking place in Taichung and Florida; however, 829 medical sites globally involve themselves in this treatment method's exploration."

Answered by AI

Is enrollment in this experiment still feasible for individuals?

"Confirmative. The clinical trial is currently recruiting, and the initial posting was on October 1st 2019. According to data hosted by clinicaltrials.gov, 375 people are needed at a single location for this research project. This information was last updated on October 25th 2021."

Answered by AI

Has Sleep Hygiene Education received regulatory sanction from the FDA?

"Power's internal team evaluates Sleep Hygiene Education to be safe enough for a 3 rating, as it is currently in Phase 4 and has been approved by medical experts."

Answered by AI

How many individuals are contributing to this experiment?

"Affirmative. The information on clinicaltrials.gov confirms that this trial is currently enlisting participants, with the first posting taking place October 1st 2019 and an update occurring shortly before October 25th 2021. 375 individuals are needed between a single medical site."

Answered by AI
~68 spots leftby Apr 2025