SleepsayedNCT02612636
The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
A study testing ear plug and eye mask in people with Sleep, run by Assiut University at 1 site in Egypt.
Trial summary
Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep
- What is being tested?
- ear plug and eye mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to May 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 years old.
- Mechanically ventilated patient.
- Conscious patient.
- No hearing problems.
- No eye disease.
- Not receiving narcotic drugs five to six hours before sleep time at night.
- No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine.
Who cannot join
- Head injury.
- Psychiatric disease.
- Shocked patients
Trial locations and contacts
1 site in 1 country.
About this study
Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.
Read the detailed description
50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).
- Conditions
- Sleep
- Being tested
- ear plug, eye mask
- Keywords
- Delirium, Ear Plug, Eye Mask, Mechanical ventilation, Sleep
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear plugOther
Also called eastnova ear plug
The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
eye maskOther
Also called Sleeping mask
The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
| Study group | Role | What they receive |
|---|---|---|
| ear plug and eye mask | Active comparator | * The patients will not receive the intervention in the first night (N1) from 9 pm to 6 am
* The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
* The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
* The patients will receive the intervention (eye mask and ear plug) in the fourth night (N4) from 9 pm to 6 am. Receives: Other: ear plug; Other: eye mask |
| control | No intervention | The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality .
to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)
Measured: four days
Secondary outcomes (3)
Urine Melatonin
as urine Melatonin ( pg/mL)
Measured: four days
Cortisol level
stress hormone as cortisol level (nmol/L)
Measured: four days
Delirium assessment
Assessment of delirium by using NEECHAM confusion scale or Nursing delirium screening scale (measured by Units on a Scale)
Measured: four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612636
- Sponsor's protocol ID
- IRB0000871100
- Acronym
- sayed
- Status last verified
- Jun 2017
- First submitted
- 16 Nov 2015
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02612636
- Acronym / sponsor ID
- sayed / IRB0000871100
- Conditions
- Sleep
- Keywords
- Delirium, Ear Plug, Eye Mask, Mechanical ventilation, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Nov 2015 (estimated)
- 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 complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.
Detailed description
50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ear plug and eye mask | Active comparator | Other: ear plug, Other: eye mask* The patients will not receive the intervention in the first night (N1) from 9 pm to 6 am * The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am. * The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am. * The patients will receive the intervention (eye mask and ear plug) in the fourth night (N4) from 9 pm to 6 am. |
| control | No intervention | –The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age >18 years old.
- Mechanically ventilated patient.
- Conscious patient.
- No hearing problems.
- No eye disease.
Key exclusion criteria (3 listed)
- Head injury.
- Psychiatric disease.
- Shocked patients
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 |
|---|---|---|
| ear plugAlso: eastnova ear plugThe patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am. | Other | ear plug and eye mask |
| eye maskAlso: Sleeping maskThe patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am. | Other | ear plug and eye mask |
Primary outcome
Sleep quality .
Time frame: four days
to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)
3 secondary outcomes
Urine Melatonin
Time frame: four days
Cortisol level
Time frame: four days
Delirium assessment
Time frame: four days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
sayed abd elshafy principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ear plug and eye mask in people with Sleep, run by Assiut University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 7 Jun 2017. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality . (time frame: four days). 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 7 Jun 2017.