Sedative Effects in Obstructive Sleep Apnea

NCT01733043 | Withdrawn Phase 2

• 1 other identifier: Pro00033021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index

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

  8 hour sleep study

Secondary Outcomes (1)

• Sleep Architecture

  During 8 hour sleep study

Study Arms (2)

Dexmedetomidine infusion

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Also known as: Precedex

Dexmedetomidine infusion

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Brian Colin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 4, 2015

Record last verified: 2015-03