Health TrialsbyHealthPanel

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

ConditionsSleep ApneaSpinal Cord Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorJohn D. Dingell VA Medical Center

About this trial

This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\>6 months post-injury).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy adults between the ages of 18 - 89

chronic spinal cord injury patients (T6 and above), > 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.

Disqualifiers

subjects ≤ 17 yrs old

Pregnant and lactating females

History of head trauma that resulted in neurological symptoms or loss of consciousness

advanced heart, lung, metabolic, liver or chronic kidney disease.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Acute episodic hypoxia

    Procedure/Surgery

    The subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period.

  • Supplemental oxygen

    Procedure/Surgery

    Supplemental oxygen therapy for 6 weeks

  • Trazodone

    Drug

    100mg before bedtime

  • Placebo

    Drug

    One placebo pill before-bedtime

  • Sham

    Procedure/Surgery

    Room air will be administered instead of episodic hypoxia or supplemental oxygen..

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Acute episodic hypoxiaExperimental treatment 2 interventions
Group B: Supplemental oxygenExperimental treatment 2 interventions
Group C: Trazodone or placeboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Tidal Volume

Change in tidal volume from baseline to recovery period.

Time frame
1 Week
2

Change in CO2 reserve (Delta-PETCO2-AT)

CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative

Time frame
1 Week
3

Change in Apnea Hypopnea Index (AHI)

AHI is used to indicate the severity of sleep apnea.

Time frame
1 week
4

Change in hypocapnic apneic threshold

The nadir pressure in the upper airway (supra-glotic pressure) prior to the occurrence of an arousal. This is a physiological parameter.

Time frame
1 week

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John D. Dingell VA Medical Center

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
Apply now