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NCT02436031 · ClinicalTrials.gov registry record · Phase 2

Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B

A Phase 2 study of Sleep Apnea, Obstructive, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 2
Development phase
16
Enrollment target
1
Study location

NCT02436031: Completed Phase 2 study of Sleep Apnea, Obstructive, sponsored by Brigham and Women's Hospital.

NCT02436031 is a Phase 2 study of Sleep Apnea, Obstructive that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02436031, a Phase 2 study of Sleep Apnea, Obstructive, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 2
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA patients.

Primary Outcome

Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventila

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Desipramine

Study Locations (1)

Massachusetts

  • Sleep Disorders Research Program Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2015-04
Est. Completion 2016-03
Phase Phase 2
Brigham and Women's Hospital

937 total trials

What the finished NCT02436031 record still lists

NCT02436031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02436031 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02436031 about?

NCT02436031 is a clinical study titled "Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B". Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. U...

What is the current status of trial NCT02436031?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-04. Estimated completion is 2016-03.

What conditions does trial NCT02436031 study?

This clinical trial studies the following conditions: Sleep Apnea, Obstructive.

What interventions are being tested in trial NCT02436031?

The interventions under investigation include: Placebo (DRUG), Desipramine (DRUG).

Who is sponsoring clinical trial NCT02436031?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02436031 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Sleep Apnea, Obstructive

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02436031's enrollment target sits among peer trials

16 43rd of 45 higher than 3 of 45 other Sleep Apnea, Obstructive trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive 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

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Source: ClinicalTrials.gov NCT02436031, the US trial registry maintained by the National Library of Medicine. NCT02436031 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.