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NCT Number: NCT06527105

Impact of Sleep Quality on Outcomes After Cardiac Surgery

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

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Key information

Conditions

Sleep Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Complications, Postoperative Confusion Delirium Delirium, Postoperative Dyssomnias Emergence Delirium Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Nagarjuna

Kochi, Kerala, 682041, India

Location status: Recruiting

Location contact

Nagarjuna P, MD, DM

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Eye masks and ear plugs

Device

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

Primary outcomes

  1. Quality of sleep

    Time frame: 6 months

    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.

Secondary outcomes

  1. Atrial fibrillation

    Time frame: 6 months

    Postoperative atrial fibrillation

  2. Delirium

    Time frame: 6 months

    Postoperative Delirium

  3. Intensive care unit stay

    Time frame: 6 months

    Duration of intensive care unit stay (in hours to days)

  4. Vasoactive inotropic score

    Time frame: 6 months

    Vasoactive inotropic score is calculated by multiplying the dose of each vasoactive drug used with 10. (minimum score is 0, while maximum score can go upto 20. Higher the score worse is the outcome

  5. Mechanical ventilation

    Time frame: 6 months

    Duration of mechanical ventilation (hours)

Study contacts

Contact information is provided by the study sponsor or research team.

Nagarjuna P

CONTACT

7981144584

Nagarjuna P, MD, DM

CONTACT

[email protected]

9177208286 ext. 091

Sponsors and collaborators

Lead sponsor

Amrita Institute of Medical Sciences & Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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