Estimating Apnea Phenotypes From Polysomnography: Oxygen (PSGtraits-O2)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Estimating Apnea Phenotypes From Routine Polysomnography: Application to Oxygen Therapy|
- The reduction in severity of sleep apnea (Apnea-Hypopnea Index, Events/hour) [ Time Frame: 1 night ] [ Designated as safety issue: No ]
Acute change in AHI is taken as the difference between values on the sham and oxygen nights, taken approximately 1 week apart.
Hypopneas are based on 30% reduction in airflow (sensitivity analysis will employ criteria using 3% desaturation and arousals)
1-way RM ANOVA will assess the reduction in AHI in patients with higher (>=0.7) and lower loop gain (<0.7); an interaction between treatment and group may indicate a preferential benefit of oxygen in those with higher loop gain.
The percentage of the night that is not interrupted by events and arousals will also be assessed (stable breathing).
- Overnight change in chemosensitivity [ Time Frame: 1 night ] [ Designated as safety issue: No ]The rise in chemosensitivity overnight will be compared between sham and oxygen treatment arms using dynamic CO2 stimulation.
- Subjective sleepiness/alertness (Stanford Sleepiness Scale) [ Time Frame: 1 night ] [ Designated as safety issue: No ]Assessed in the morning after the single night of oxygen/air, and compared between sham and oxygen studies.
- Overnight change in blood pressure [ Time Frame: 1 night ] [ Designated as safety issue: No ]The change in blood pressure overnight will be assessed in both studies, and compared between sham and oxygen studies approximately 1 week apart.
- Subjective sleep quality (oxygen vs sham) [ Time Frame: 1 night ] [ Designated as safety issue: No ]Better(+1)/Same(0)/Worse(-1) on oxygen vs sham
- Frequency of EEG arousals (events per hour) [ Time Frame: 1 night ] [ Designated as safety issue: No ]To complement findings of changes in AHI, we will examine the frequency of arousals from sleep. The proportion of light sleep will also be assessed.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Oxygen First
Participants participate in inspired oxygen arm (40% oxygen) first, then the air night (21% oxygen) second
Drug: Inspired oxygen (40%)
Supplemental oxygen at approximately 40% e.g. via Pink venturi mask
Other Name: Supplemental oxygen
Placebo Comparator: Air First
Participants participate in the air night (sham) first, then the oxygen night second.
Medical air with 21% oxygen e.g. via Pink venturi mask
Other Name: Medical air
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751971
|Contact: SCOTT A SANDS, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Scott SANDS, PhD email@example.com|
|Principal Investigator:||SCOTT A Sands, PhD||Brigham and Women's Hospital|