Trial · NCT02458469

Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

NCT02458469, Phase 2, Completed, VA Office of Research and Development; results first posted 2020-04-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI. Trials, record NCT02458469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02458469

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI
NCT number: NCT02458469
Status: Completed
Phases: Phase 2
Enrollment: 15 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Spinal Cord Injury, Sleep Disordered Breathing
Interventions: Buspirone, Trazodone, Placebo
First posted: 2015-06-01
Last updated: 2021-06-14
Results first posted: 2020-04-09
Limitations and caveats: * The sample size is small and the majority are males, therefore findings from this study may not be applicable to the general population~* The study required heavy instrumentation which may have affected natural sleep

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	CO2 Reserve (Delta-PETCO2-AT)	Two weeks	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.
Secondary	Apnea-Hypopnea Index (AHI)	Two weeks	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	CO2 Reserve (Delta-PETCO2-AT)	Two weeks	Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.	mmHg	MEAN
SECONDARY	Apnea-Hypopnea Index (AHI)	Two weeks	Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.	Events/Hour	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
CO2 Reserve (Delta-PETCO2-AT)	Buspirone	-3.6	Standard Deviation 0.9	mmHg
CO2 Reserve (Delta-PETCO2-AT)	Trazodone	-2.5	Standard Deviation 1.0	mmHg
CO2 Reserve (Delta-PETCO2-AT)	Placebo	-1.8	Standard Deviation 1.5	mmHg
Apnea-Hypopnea Index (AHI)	Buspirone	48.7	Standard Deviation 21.4	Events/Hour
Apnea-Hypopnea Index (AHI)	Trazodone	40.0	Standard Deviation 23.9	Events/Hour
Apnea-Hypopnea Index (AHI)	Placebo	45.2	Standard Deviation 23.2	Events/Hour

Source ClinicalTrials.gov

Participant flow90

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (2 Weeks)	STARTED	Placebo->Buspirone->Trazodone	3
First Intervention (2 Weeks)	STARTED	Placebo->Trazodone->Buspirone	2
First Intervention (2 Weeks)	STARTED	Buspirone->Trazodone->Placebo	3
First Intervention (2 Weeks)	STARTED	Buspirone->Placebo->Trazodone	0
First Intervention (2 Weeks)	STARTED	Trazodone->Placebo->Buspirone	1
First Intervention (2 Weeks)	STARTED	Trazodone->Buspirone->Placebo	2
First Intervention (2 Weeks)	COMPLETED	Placebo->Buspirone->Trazodone	2
First Intervention (2 Weeks)	COMPLETED	Placebo->Trazodone->Buspirone	2
First Intervention (2 Weeks)	COMPLETED	Buspirone->Trazodone->Placebo	2
First Intervention (2 Weeks)	COMPLETED	Buspirone->Placebo->Trazodone	0

1 to 10 of 90Source ClinicalTrials.gov

See all 90 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Buspirone	1	10	1
other	Nausea	Gastrointestinal disorders	Trazodone	0	9	0
other	Nausea	Gastrointestinal disorders	Placebo	0	9	0
other	Headache	General disorders	Buspirone	1	10	1
other	Headache	General disorders	Trazodone	0	9	0
other	Headache	General disorders	Placebo	0	9	0
other	Fatigue	General disorders	Buspirone	1	10	1
other	Fatigue	General disorders	Trazodone	0	9	0
other	Fatigue	General disorders	Placebo	0	9	0
serious	Suicidal Thoughts	Psychiatric disorders	Buspirone	0	10	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Buspirone	0	10
Total, all-cause mortality	Trazodone	0	9
Total, all-cause mortality	Placebo	0	9
Total, other adverse events	Buspirone	3	10
Total, other adverse events	Trazodone	0	9
Total, other adverse events	Placebo	0	9
Total, serious adverse events	Buspirone	0	10
Total, serious adverse events	Trazodone	0	9
Total, serious adverse events	Placebo	1	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
IK2CX000547	Pathogenesis of Sleep Disordered Breathing in Spinal Cord Injury Patients	SANKARI, ABDULGHANI	JOHN D DINGELL VA MEDICAL CENTER	Veterans Affairs	2013 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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