NCT01816685

Brief Summary

Patients with a medical condition known as obstructive sleep apnea may be at increased risk of delirium following surgery. This study loans autotitrating CPAP machines to randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of preventing post-operative delirium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 31, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

March 20, 2013

Results QC Date

June 28, 2015

Last Update Submit

August 4, 2015

Conditions

Sleep Apnea, ObstructiveDelirium

Outcome Measures

Primary Outcomes (2)

  • Presence of Postoperative Delirium

    Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.

    Postoperative day 2

  • Presence of Postoperative Delirium

    Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium

    Postoperative day 2

Study Arms (2)

CPAP

EXPERIMENTAL

Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.

Device: CPAP

Routine Care

NO INTERVENTION

Interventions

CPAPDEVICE
CPAP

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 and above
  • Scheduled for an elective knee or hip replacement
  • Ability to speak English and give informed consent
  • At risk for obstructive sleep apnea as defined by a STOP-BANG score \> 2

You may not qualify if:

  • History of psychiatric or neurologic illness that would confound delirium assessment
  • Severe tracheal or lung disease
  • Contraindications to face-mask CPAP
  • Treated OSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

  • Evans JL, Nadler JW, Preud'homme XA, Fang E, Daughtry RL, Chapman JB, Attarian D, Wellman S, Krystal AD. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium. Clin Neurophysiol. 2017 Aug;128(8):1421-1425. doi: 10.1016/j.clinph.2017.05.004. Epub 2017 May 17.

    PMID: 28618293DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDelirium

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Andrew Krystal
Organization
Duke University
andrew.krystal@dm.duke.edu
(919) 668-1212

Study Officials

  • Andrew Krystal, MD

    Department of Psychiatry, Duke University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 31, 2015

Results First Posted

August 31, 2015

Record last verified: 2015-08

Locations

US(1)