Obstructive Sleep Apnea (OSA)
Conditions
Brief 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 subjects. In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.
Interventions
DRUGPlacebo oral capsule
Placebo before sleep
DRUGDAW1033D oral capsule
DAW1033D before sleep
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- AHI \> 15
Exclusion criteria
* Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia * Any medication known to influence breathing, sleep/arousal or muscle physiology. * Claustrophobia. * Inability to sleep supine. * Allergy to lidocaine, Oxymetazoline HCl, DAW1033D. * Individuals with underlying cardiac disease, such as arrhythmias. * Individuals taking psychiatric medications, or any of the studied medications for medical care. * History of seizures * For women: Pregnancy. * History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI, Events/Hour of Sleep) | 1 night | Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collapsibility of the Upper Airway: VPassive | 1 night | Ventilation when ventilatory drive is relatively low during sleep |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Analyzed Participants All participants who were randomized, completed both study nights, and were included in the analysis. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | All Analyzed Participants |
|---|---|
| Age, Continuous | 53 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.
Time frame: 1 night
Population: 1 participant was not analyzed because he dropped out between the 2 intervention arms
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Apnea Hypopnea Index (AHI, Events/Hour of Sleep) | 21.6 events/hour of sleep |
| DAW1033D | Apnea Hypopnea Index (AHI, Events/Hour of Sleep) | 37.9 events/hour of sleep |
p-value: 0.56Wilcoxon (Mann-Whitney)
Secondary
Collapsibility of the Upper Airway: VPassive
Ventilation when ventilatory drive is relatively low during sleep
Time frame: 1 night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Collapsibility of the Upper Airway: VPassive | 74.8 % eupneic ventilation |
| DAW1033D | Collapsibility of the Upper Airway: VPassive | 92.7 % eupneic ventilation |
p-value: 0.027Wilcoxon (Mann-Whitney)