Trial Outcomes & Findings for Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI (NCT NCT02458469)
NCT ID: NCT02458469
Last Updated: 2021-06-14
Results Overview
Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a noninvasive nasal mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) Cross over medication for two weeks was followed by a second noninvasive nasal mechanical ventilation study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the hypocapnic apneic threshold.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Two weeks
Results posted on
2021-06-14
Participant Flow
Participants were recruited to the primary site at John D. Dingell VA Medical Center.
Of 150 available, 15 participants were enrolled. Of the 15 enrolled, 11 started the study protocol.
Participant milestones
| Measure |
Placebo->Buspirone->Trazodone
Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks.
|
Placebo->Trazodone->Buspirone
Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks.
|
Buspirone->Trazodone->Placebo
Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks.
|
Buspirone->Placebo->Trazodone
Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks.
|
Trazodone->Placebo->Buspirone
Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks.
|
Trazodone->Buspirone->Placebo
Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks.
|
|---|---|---|---|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
3
|
2
|
3
|
0
|
1
|
2
|
|
First Intervention (2 Weeks)
COMPLETED
|
2
|
2
|
2
|
0
|
1
|
2
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
0
|
|
First Washout (2 Weeks)
STARTED
|
2
|
2
|
2
|
0
|
1
|
2
|
|
First Washout (2 Weeks)
COMPLETED
|
2
|
2
|
2
|
0
|
1
|
2
|
|
First Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
2
|
2
|
2
|
0
|
1
|
2
|
|
Second Intervention (2 Weeks)
COMPLETED
|
2
|
2
|
2
|
0
|
1
|
1
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Second Washout (2 Weeks)
STARTED
|
2
|
2
|
2
|
0
|
1
|
1
|
|
Second Washout (2 Weeks)
COMPLETED
|
2
|
2
|
2
|
0
|
1
|
1
|
|
Second Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (2 Weeks)
STARTED
|
2
|
2
|
2
|
0
|
1
|
1
|
|
Third Intervention (2 Weeks)
COMPLETED
|
2
|
2
|
2
|
0
|
1
|
1
|
|
Third Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo->Buspirone->Trazodone
Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks.
|
Placebo->Trazodone->Buspirone
Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks.
|
Buspirone->Trazodone->Placebo
Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks.
|
Buspirone->Placebo->Trazodone
Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks.
|
Trazodone->Placebo->Buspirone
Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks.
|
Trazodone->Buspirone->Placebo
Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks.
|
|---|---|---|---|---|---|---|
|
First Intervention (2 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Intervention (2 Weeks)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (2 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
Participants who were randomized to receive either Buspirone (7.5-15 mg) or Trazodone (100 mg) or Placebo tablet
|
|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two weeksPopulation: Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.
Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a noninvasive nasal mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) Cross over medication for two weeks was followed by a second noninvasive nasal mechanical ventilation study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the hypocapnic apneic threshold.
Outcome measures
| Measure |
Buspirone
n=8 Participants
This drug will be taken for two week period
Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
|
Trazodone
n=8 Participants
This drug will be taken for two week period
Trazodone: 100 mg dose before bed-time
|
Placebo
n=8 Participants
A placebo pill will be taken at bed time for two week period
Placebo: One placebo pill before bed-time
|
|---|---|---|---|
|
CO2 Reserve (Delta-PETCO2-AT)
|
-3.6 mmHg
Standard Deviation 0.9
|
-2.5 mmHg
Standard Deviation 1.0
|
-1.8 mmHg
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Two weeksPopulation: Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.
Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a polysomnogram (PSG) study was repeated to determine the AHI. (2) Cross over medication for two weeks was followed by a second PSG to determine the AHI followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the AHI.
Outcome measures
| Measure |
Buspirone
n=8 Participants
This drug will be taken for two week period
Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
|
Trazodone
n=8 Participants
This drug will be taken for two week period
Trazodone: 100 mg dose before bed-time
|
Placebo
n=8 Participants
A placebo pill will be taken at bed time for two week period
Placebo: One placebo pill before bed-time
|
|---|---|---|---|
|
Apnea-Hypopnea Index (AHI)
|
48.7 Events/Hour
Standard Deviation 21.4
|
40.0 Events/Hour
Standard Deviation 23.9
|
45.2 Events/Hour
Standard Deviation 23.2
|
Adverse Events
Buspirone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Trazodone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buspirone
n=10 participants at risk
This drug will be taken for two week period
Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
|
Trazodone
n=9 participants at risk
This drug will be taken for two week period
Trazodone: 100 mg dose before bed-time
|
Placebo
n=9 participants at risk
A placebo pill will be taken at bed time for two week period
Placebo: One placebo pill before bed-time
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal Thoughts
|
0.00%
0/10 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
Other adverse events
| Measure |
Buspirone
n=10 participants at risk
This drug will be taken for two week period
Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
|
Trazodone
n=9 participants at risk
This drug will be taken for two week period
Trazodone: 100 mg dose before bed-time
|
Placebo
n=9 participants at risk
A placebo pill will be taken at bed time for two week period
Placebo: One placebo pill before bed-time
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
0.00%
0/9 • Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.
Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.
|
Additional Information
Dr. Abdulghani Sankari Principal Investigator
JOHN D DINGELL VA MEDICAL CENTER
Phone: 13135761000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place