Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06527105

The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients

Led by Amrita Institute of Medical Sciences & Research Center · Updated on 2024-09-25

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Sleep is a vital human need essential for good health and quality of life, yet it is often overlooked in intensive care units (ICUs) where patients experience significant sleep deprivation. This deprivation can lead to negative effects such as brain dysfunction, including inattention, restlessness, hallucinations, agitation, and cognitive impairments ranging from confusion to delirium. It may also contribute to hypertension, fatigue, metabolic disorders, and cardiovascular complications, especially in patients undergoing cardiac surgery. This research evaluates the impact of non-drug interventions using eye masks and ear plugs during sleep in the ICU after cardiac surgery. Patients are randomly assigned to either receive these devices during sleep or to receive routine care without any intervention. The study compares sleep quality and postoperative complications across these groups over a six-month period. Participants will be monitored for sleep quality and other health outcomes such as atrial fibrillation, delirium, ICU stay length, vasoactive inotropic score, and mechanical ventilation duration. The study involves follow-up assessments over six months to understand how these interventions affect recovery and complications after cardiac surgery. The trial is sponsored by Amrita Institute of Medical Sciences & Research Center and includes adults aged 18 to 80 years undergoing elective cardiac surgery.

CONDITIONS

Brief Title

Impact of Sleep Quality on Outcomes After Cardiac Surgery

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult cardiac surgical patients aged above 18 years undergoing elective cardiac surgery
Not Eligible

You will not qualify if you...

  • Not willing to give consent
  • Use of sleep medications before surgery
  • Presence of psychological disorders before surgery
  • Mechanical ventilation for more than 12 hours
  • Dementia
  • History of cerebrovascular accident

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - During hospital stay post-surgery

Participants undergo elective cardiac surgery and receive either eye masks and ear plugs during sleep in the ICU or routine care without intervention.

Daily assessments during ICU stay

Follow-up

Duration - 6 months

Participants are observed for outcomes including quality of sleep, atrial fibrillation, delirium, ICU stay, vasoactive inotropic score, and mechanical ventilation over 6 months.

Periodic visits or contacts over 6 months

Trial Site Locations

Total: 1 location

1

Dr. Nagarjuna

Kochi, Kerala, India, 682041

Actively Recruiting

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Research Team

N

Nagarjuna P, MD, DM

N

Nagarjuna P

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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