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Sedative Effects in Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01733043
Recruitment Status : Withdrawn (Failure to secure funding)
First Posted : November 26, 2012
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The objective of this study is to determine the effect of dexmedetomidine infusion on the Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with obstructive sleep apnea (OSA).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Dexmedetomidine Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexmedetomidine for Sedation in Individuals With Obstructive Sleep Apnea
Study Start Date : March 2015
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexmedetomidine infusion
Dexmedetomidine 0.5 mcg/kg loading dose administered over 20 minutes, followed by 0.6 mcg/kg/hr infusion for 1 hour and 40 minutes
 Drug: Dexmedetomidine
Other Name: Precedex
Placebo Comparator: Placebo
Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Apnea Hypopnea Index [ Time Frame: 8 hour sleep study ]
    The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index


Secondary Outcome Measures :
  1. Sleep Architecture [ Time Frame: During 8 hour sleep study ]
    Additional measures of sleep architecture will be made: sleep onset latency, duration of time spent in rapid eye movement (REM) and non-rapid eye movement (NREM) sleep, sleep efficiency, and number of arousals


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All individuals who have previously undergone diagnostic polysomnography in the Sleep Lab which documented significant OSA, and who have not undergone any changes that are likely to alter the severity of their condition since the time of their diagnostic sleep study (loss of weight; surgical therapy for OSA; removal of tonsils; discontinuation of medications likely to affect arousal or respiratory function, etc.) are eligible to participate. Subjects will be identified as they complete outpatient sleep studies or from records of previous sleep studies performed in the Duke Sleep Laboratory. After obtaining informed consent, subjects will be screened by history and physical examination, 12-lead electrocardiogram, and comprehensive metabolic profile.

Exclusion Criteria:

  • Exclusion criteria will include a history of illicit drug or alcohol dependence, impaired hepatic (aspartate aminotransferase or alanine aminotransferase > 2x upper limit of normal range) or renal function (receiving dialysis or serum creatinine > 1.5 mg/dL), high-grade (> 1st degree) heart block, or known allergy to dexmedetomidine.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733043


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Brian Colin, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01733043    
Other Study ID Numbers: Pro00033021
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Dexmedetomidine
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action