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WithdrawnNCT01733043Updated Mar 4, 2015

Sedative Effects in Obstructive Sleep Apnea

A Phase 2/3 interventional study of Dexmedetomidine and Placebo in Obstructive Sleep Apnea, sponsored by Duke University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-04.

Sponsored by Duke University · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Failure to secure funding
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Obstructive Sleep Apnea
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

Browse Apnea studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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:

  • 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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

    Normal saline infusions will be administered over 4 hours at rates mimicking the DEX infusion rate

    Drug: Placebo

Interventions

  • DrugDexmedetomidine

    Also known as: Precedex

  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. Apnea Hypopnea Index

    The primary outcome is frequency of apnea or hypopnea as measured by the apnea hypopnea index

    Time frame: 8 hour sleep study

Secondary outcomes

  1. Sleep Architecture

    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

    Time frame: During 8 hour sleep study

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01733043
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Nov 26, 2012
Start date
Mar 2015
Primary completion
May 2015 (estimated)
Completion
Nov 2015 (estimated)
Last update
Mar 4, 2015

Study contacts

Brian Colin, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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