Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01045122 · ClinicalTrials.gov registry record · NA

Sedation in Patients at Risk for Upper Airway Collapse

A NA study, sponsored by University of Rochester.

Completed
Registry status
NA
Development phase
15
Enrollment target

NCT01045122: Completed NA study, sponsored by University of Rochester.

NCT01045122 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01045122, a NA study, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target

Study Summary

Overview of Protocol: Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\< 10 RDI or \> 25 RDI). Some subjects will have been prescribed continuous positive airway pressure (CPAP) therapy by their treating physician as a result of their overnight sleep study. CPAP treatment is effective in splinting the airway open and thus decreasing the incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an independent and continuous variable as regular CPAP use has been found to be associated with increased resistance to UAC (upper airway collapse). The experimental conditions will evaluate upper airway patency and instability in response to two forms of intravenous sedation: propofol and dexmedetomidine. Subjects will be continuously monitored during each experimental condition for respiratory effort and flow, and for EEG, EMG, and ECG. Respiratory instability will first be assessed while subjects are under sedation without any airway provocation. The degree of respiratory instability will be quantified in terms of the following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory arousals, and minute ventilation. The apneic periods will be classified by their mixture of central and obstructive components.All outcome measurements are assessed over the period of sedation which last for approximately one hour. Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit) (the pressure beyond which complete upper airway collapse occurs, see background).

Primary Outcome

respiratory events (apneas, hypopneas) per hour

Interventions

  • DRUG Dexmedetomidine
  • DRUG Propofol

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2006-12
Est. Completion 2008-10
Phase NA
University of Rochester

636 total trials

What the finished NCT01045122 record still lists

NCT01045122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine is the first listed.

NCT01045122 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01045122 about?

NCT01045122 is a clinical study titled "Sedation in Patients at Risk for Upper Airway Collapse". Overview of Protocol: Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\<...

What is the current status of trial NCT01045122?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2006-12. Estimated completion is 2008-10.

What interventions are being tested in trial NCT01045122?

The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG).

Who is sponsoring clinical trial NCT01045122?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01045122's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01889381 · 15 participants · Phase 2

    Human Craniomaxillofacial Allotransplantation

  • NCT02530073 · 15 participants · NA

    Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

  • NCT02535936 · 15 participants · NA

    Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

  • NCT02918474 · 15 participants · NA

    Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01045122, the US trial registry maintained by the National Library of Medicine. NCT01045122 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.