N/A
N=22
Combination Therapy to Treat Sleep Apnea
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01633827 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Model Prediction of Absence/Presence of OSA: Ventilation That Causes an Arousal From Sleep (Varousal) — 5.7; 5.2 L/min — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo pill (Drug); Sedative (Drug); Room air (Other); Oxygen (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Model Prediction of Absence/Presence of OSA: Ventilation That Causes an Arousal From Sleep (Varousal) |
5.7; 5.2 | 0.05 |
| PRIMARY Model Prediction of Absence/Presence of OSA: Ventilatory Control Sensitivity (Loop Gain) |
3.3; 2.20 | 0.025 sig |
| PRIMARY Model Prediction of Absence/Presence of OSA: Passive Collapsibility |
1.40; 1.20 | 0.5 |
| PRIMARY Model Prediction of Absence/Presence of OSA: Active Collapsibility (Vactive) |
4.4; 4 | 0.5 |
| SECONDARY Apnea-Hypopnea Index |
51.9; 29.5 | 0.001 sig |
Summary
In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep. This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an increased risk for developing high blood pressure. Currently, the best treatment for obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the upper airway from closing in most people, many people have difficulty sleeping with the mask in place and therefore do not use the CPAP treatment. This research study is being conducted to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will improve OSA severity by altering some of the traits that are responsible for the disorder.
Eligibility Criteria
Inclusion Criteria
- Ages 18 - 79 years
- Documented OSA (AHI > 10 events/hr Non rapid eye movement sleep supine)
- If treated then, current CPAP use (>4 hrs CPAP/night for > 2 months)
Exclusion Criteria
- Any uncontrolled medical condition
- Any other sleep disorder (Periodic leg movement syndrome, restless legs syndrome, insomnia, etc.)
- Use of medications known to affect sleep/arousal, breathing, or muscle physiology
- Allergy to lidocaine or Afrin
- Claustrophobia
- Alcohol consumption within 24 hours of PSG
Data sourced from ClinicalTrials.gov (NCT01633827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.