Sleep DeprivationNCT01057823
Understanding Sleep in Hospitalized Older Patients
An observational study of Sleep Deprivation and Sleep Fragmentation, run by University of Chicago at 1 site in United States.
Trial summary
The overall goal of this research is to elucidate how environmental, healthcare, and patient-level factors and patients' level of perceived control impact sleep duration and quality in hospitalized older patients and to assess whether better in-hospital sleep is associated with improved physical activity and health… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Deprivation, Sleep Fragmentation
- How many people
- 771 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 19 Jul 2020
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community-dwelling ambulatory patients age 50 or above hospitalized on the University of Chicago general medicine service.
Who may be able to join
- Age 50 or above
- Hospitalized on General Medicine service
- Ambulatory
- Community Dwelling
- MMSE >17
Who cannot join
- transfer from the ICU or another hospital
- cognitively impaired
- not ambulatory
- residents of a nursing home or skilled nursing facility
- on bedrest
- documented sleep disorder in their medical history
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Environment and Perceived Control: Improving Sleep in Hospitalized Older Patients
The overall goal of this research is to elucidate how environmental, healthcare, and patient-level factors and patients' level of perceived control impact sleep duration and quality in hospitalized older patients and to assess whether better in-hospital sleep is associated with improved physical activity and health outcomes.
We hypothesize that environment, healthcare disruptions and patient symptoms will be significantly associated with objective and subjective sleep duration and sleep quality in hospitalized older patients.
Read more
We also hypothesize that a high level of perceived control will be associated with improved sleep duration and quality in hospitalized older patients.
We further hypothesize that shorter sleep duration and quality in hospitalized older adults will be associated with adverse health outcomes, namely higher blood pressure and blood sugar.
Read the detailed description
This research can lead to a better understanding of the effects of inpatient sleep on health outcomes for hospitalized older patients and can help inform the design and evaluation of interventions designed to improve sleep in hospitalized older patients. This work can also form the foundation for understanding the longer term health effects of inpatient sleep loss for older patients that are potentially modifiable.
- Conditions
- Sleep Deprivation, Sleep Fragmentation
- Keywords
- aged, sleep deprivation, actigraphy, ambulatory monitoring
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Elders Age 50 and up | The study population is community-dwelling ambulatory patients age 50 or above hospitalized on the University of Chicago general medicine service. Exclusion criteria include: (1) transfer from the ICU or another hospital; (2) cognitively impaired; (3) not ambulatory; (4) residents of a nursing home or skilled nursing facility; (5) on bedrest; (6)documented sleep disorder in their medical history (i.e. obstructive sleep apnea, narcolepsy, etc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment).
Measured: January 2010-January 2015
Secondary outcomes (1)
Sleep will also be measured objectively using actigraphy.
Measured: January 2010-January 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completion19 Jul 2019
- Study completion19 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Vineet M Arora, MD, MA, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057823
- Sponsor's protocol ID
- 16685B
- Other IDs
- 1K23AG033763-01
- Status last verified
- May 2021
- First submitted
- 26 Jan 2010
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Arora VM, Chang KL, Fazal AZ, Staisiunas PG, Meltzer DO, Zee PC, Knutson KL, Van Cauter E. Objective sleep duration and quality in hospitalized older adults: associations with blood pressure and mood. J Am Geriatr Soc. 2011 Nov;59(11):2185-6. doi: 10.1111/j.1532-5415.2011.03644.x. No abstract available.
PubMed 22098044Yoder JC, Staisiunas PG, Meltzer DO, Knutson KL, Arora VM. Noise and sleep among adult medical inpatients: far from a quiet night. Arch Intern Med. 2012 Jan 9;172(1):68-70. doi: 10.1001/archinternmed.2011.603. No abstract available.
PubMed 22232151Adachi M, Staisiunas PG, Knutson KL, Beveridge C, Meltzer DO, Arora VM. Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013 Apr;8(4):184-90. doi: 10.1002/jhm.2027. Epub 2013 Mar 18.
PubMed 23504939DePietro RH, Knutson KL, Spampinato L, Anderson SL, Meltzer DO, Van Cauter E, Arora VM. Association Between Inpatient Sleep Loss and Hyperglycemia of Hospitalization. Diabetes Care. 2017 Feb;40(2):188-193. doi: 10.2337/dc16-1683. Epub 2016 Nov 30.
PubMed 27903614
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environment and Perceived Control: Improving Sleep in Hospitalized Older Patients
- ClinicalTrials.gov ID
- NCT01057823
- Acronym / sponsor ID
- 16685B
- Conditions
- Sleep Deprivation, Sleep Fragmentation
- Keywords
- aged, sleep deprivation, actigraphy, ambulatory monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2010
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2020 (actual)
- First posted
- 27 Jan 2010 (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.
The overall goal of this research is to elucidate how environmental, healthcare, and patient-level factors and patients' level of perceived control impact sleep duration and quality in hospitalized older patients and to assess whether better in-hospital sleep is associated with improved physical activity and health outcomes.
We hypothesize that environment, healthcare disruptions and patient symptoms will be significantly associated with objective and subjective sleep duration and sleep quality in hospitalized older patients.
We also hypothesize that a high level of perceived control will be associated with improved sleep duration and quality in hospitalized older patients.
We further hypothesize that shorter sleep duration and quality in hospitalized older adults will be associated with adverse health outcomes, namely higher blood pressure and blood sugar.
Detailed description
This research can lead to a better understanding of the effects of inpatient sleep on health outcomes for hospitalized older patients and can help inform the design and evaluation of interventions designed to improve sleep in hospitalized older patients. This work can also form the foundation for understanding the longer term health effects of inpatient sleep loss for older patients that are potentially modifiable.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient Elders Age 50 and up | – | –The study population is community-dwelling ambulatory patients age 50 or above hospitalized on the University of Chicago general medicine service. Exclusion criteria include: (1) transfer from the ICU or another hospital; (2) cognitively impaired; (3) not ambulatory; (4) residents of a nursing home or skilled nursing facility; (5) on bedrest; (6)documented sleep disorder in their medical history (i.e. obstructive sleep apnea, narcolepsy, etc). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling ambulatory patients age 50 or above hospitalized on the University of Chicago general medicine service.
Key inclusion criteria (5 listed)
- Age 50 or above
- Hospitalized on General Medicine service
- Ambulatory
- Community Dwelling
- MMSE >17
Key exclusion criteria (6 listed)
- transfer from the ICU or another hospital
- cognitively impaired
- not ambulatory
- residents of a nursing home or skilled nursing facility
- on bedrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment).
Time frame: January 2010-January 2015
1 secondary outcome
Sleep will also be measured objectively using actigraphy.
Time frame: January 2010-January 2015
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 17 May 2021.
- Results publication: PubMed 22098044Arora VM, Chang KL, Fazal AZ, Staisiunas PG, Meltzer DO, Zee PC, Knutson KL, Van Cauter E. Objective sleep duration and quality in hospitalized older adults: associations with blood pressure and mood. J Am Geriatr Soc. 2011 Nov;59(11):2185-6. doi: 10.1111/j.1532-5415.2011.03644.x. No abstract available.
- Results publication: PubMed 22232151Yoder JC, Staisiunas PG, Meltzer DO, Knutson KL, Arora VM. Noise and sleep among adult medical inpatients: far from a quiet night. Arch Intern Med. 2012 Jan 9;172(1):68-70. doi: 10.1001/archinternmed.2011.603. No abstract available.
- Results publication: PubMed 23504939Adachi M, Staisiunas PG, Knutson KL, Beveridge C, Meltzer DO, Arora VM. Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013 Apr;8(4):184-90. doi: 10.1002/jhm.2027. Epub 2013 Mar 18.
- Derived from this study: PubMed 27903614DePietro RH, Knutson KL, Spampinato L, Anderson SL, Meltzer DO, Van Cauter E, Arora VM. Association Between Inpatient Sleep Loss and Hyperglycemia of Hospitalization. Diabetes Care. 2017 Feb;40(2):188-193. doi: 10.2337/dc16-1683. Epub 2016 Nov 30.
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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.
Vineet M Arora, MD, MA principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation and Sleep Fragmentation, run by University of Chicago at 1 site in United States.
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 5 inclusion and 6 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 17 May 2021. 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 United States. 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 will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment). (time frame: January 2010-January 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057823, which also lists 4 linked publications.
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 17 May 2021.