SleepNCT06527105
Impact of Sleep Quality on Outcomes After Cardiac Surgery
A study testing Eye masks and ear plugs in people with Sleep and Atrial Fibrillation, run by Amrita Institute of Medical Sciences & Research Center at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Atrial Fibrillation, Delirium, Postoperative
- What is being tested?
- Eye masks and ear plugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jul 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery
Who cannot join
- Not willing to give consent
- Preoperative sleep medications use
- Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident
Trial locations and contacts
1 site in 1 country.
Nagarjuna P contact
India1 site, 1 recruiting
- Recruiting
Dr. Nagarjuna
Kochi, Kerala, 682041
Nagarjuna P, MD, DM
About this study
Official title: The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
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
- Being tested
- Eye masks and ear plugs
- Keywords
- Cardiac surgery, Sleep quality
- Medical subject headings
- Atrial Fibrillation, Emergence Delirium, Postoperative Complications, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye masks and ear plugsDevice
Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Active comparator | Eye masks and Ear plugs given during sleep Receives: Device: Eye masks and ear plugs |
| Control group | No intervention | Routine care given without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Atrial fibrillation
Postoperative atrial fibrillation
Measured: 6 months
Delirium
Postoperative Delirium
Measured: 6 months
Intensive care unit stay
Duration of intensive care unit stay (in hours to days)
Measured: 6 months
Vasoactive inotropic score
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
Measured: 6 months
Mechanical ventilation
Duration of mechanical ventilation (hours)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start22 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amrita Institute of Medical Sciences & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagarjuna P, Amrita Institute of Medical Sciences & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527105
- Sponsor's protocol ID
- IEC-AIMS-2023-CARDANES-009
- Status last verified
- Sep 2024
- First submitted
- 23 Jul 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT06527105
- Acronym / sponsor ID
- IEC-AIMS-2023-CARDANES-009
- Keywords
- Cardiac surgery, Sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amrita Institute of Medical Sciences & Research CenterUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Active comparator | Device: Eye masks and ear plugsEye masks and Ear plugs given during sleep |
| Control group | No intervention | –Routine care given without any intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery
Key exclusion criteria (3 listed)
- Not willing to give consent
- Preoperative sleep medications use
- Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye masks and ear plugsEye masks and ear plugs given during sleeping time in Icu After cardiac surgery | Device | Interventional group |
Primary outcome
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.
5 secondary outcomes
Atrial fibrillation
Time frame: 6 months
Delirium
Time frame: 6 months
Intensive care unit stay
Time frame: 6 months
Vasoactive inotropic score
Time frame: 6 months
Mechanical ventilation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagarjuna P contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye masks and ear plugs in people with Sleep and Atrial Fibrillation, run by Amrita Institute of Medical Sciences & Research Center at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagarjuna P, MD, DM (9177208286 ext. 091, drarjun83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.