Impact of Sleep Quality on Outcomes After Cardiac Surgery

NCT06527105 | Recruiting DMC

• 1 other identifier: IEC-AIMS-2023-CARDANES-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU. The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease

Conditions

Sleep; Atrial Fibrillation; Delirium, Postoperative; Complications, Postoperative

Keywords

Cardiac surgery; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Quality of sleep

  On the morning after the intervention, patient's sleep quality will be assessed using Richard-Campbell sleep questionnaire (RCSQ). Each point in RCSQ will be scored using a visual analog score, ranging from 0-100. Total score will be calculated and then will be divided by 5.

  6 months

Secondary Outcomes (5)

• Atrial fibrillation

  6 months

• Delirium

  6 months

• Intensive care unit stay

  6 months

• Vasoactive inotropic score

  6 months

• Mechanical ventilation

  6 months

Study Arms (2)

Interventional group

ACTIVE COMPARATOR

Eye masks and Ear plugs given during sleep

Device: Eye masks and ear plugs

Control group

NO INTERVENTION

Routine care given without any intervention

Interventions

Eye masks and ear plugs DEVICE

Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery

Interventional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery

You may not qualify if:

• Not willing to give consent
• Preoperative sleep medications use
• Preoperative psychological disorders, on mechanical ventilation for \>12hrs, dementia, cerebrovascular accident

Sponsors & Collaborators

• Amrita Institute of Medical Sciences & Research Center: lead

Study Sites (1)

Dr. Nagarjuna

Kochi, Kerala, 682041, India

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Emergence Delirium; Postoperative Complications; Sleep Initiation and Maintenance Disorders

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Nagarjuna P, MD, DM

CONTACT

9177208286; drarjun83@gmail.com

Nagarjuna P

CONTACT

7981144584

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Cardiac Anesthesia

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 30, 2024
• Study Start: July 22, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)