Trial · NCT05041322
Improving Ventilatory Capacity in Those With Chronic High Level SCI
NCT05041322, Phase 2, Completed, Spaulding Rehabilitation Hospital; results first posted 2025-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Ventilatory Capacity in Those With Chronic High Level SCI. Trials, record NCT05041322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05041322
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Ventilatory Capacity in Those With Chronic High Level SCI
- NCT number
- NCT05041322
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Conditions
- Spinal Cord Injuries
- Interventions
- Buspirone, Placebo
- First posted
- 2021-09-13
- Last updated
- 2025-09-18
- Results first posted
- 2025-09-18
- Limitations and caveats
- Insufficient sample size to make any determination of efficacy.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulmonary Function | 14 Days | Forced expiratory volume over 1 second (FEV1). |
| Primary | Hypercapnic Ventilatory Response | 14 Days | A change in the drive to breathe with a change in carbon dioxide |
| Primary | Sleep Quality | 14 Days | Sleep apneas and hypopneas per hour. |
| Primary | Exercise Pulmonary Capacity | 14 Days | Change in peak oxygen consumption during exercise |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulmonary Function | 14 Days | L | MEAN | |
| PRIMARY | Hypercapnic Ventilatory Response | 14 Days | L /min/mmHg of CO2 | MEAN | |
| PRIMARY | Sleep Quality | 14 Days | counts per hour | MEAN | |
| PRIMARY | Exercise Pulmonary Capacity | 14 Days | ml/kg of O2 | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulmonary Function | Placebo | 3.59 | Standard Deviation 1.07 | L | |
| Pulmonary Function | Buspirone | 3.77 | Standard Deviation 1.12 | L | |
| Hypercapnic Ventilatory Response | Placebo | 0.659 | Standard Deviation 0.320 | L /min/mmHg of CO2 | |
| Hypercapnic Ventilatory Response | Buspirone | 0.566 | Standard Deviation 0.133 | L /min/mmHg of CO2 | |
| Sleep Quality | Placebo | 4.26 | Standard Deviation 2.11 | counts per hour | |
| Sleep Quality | Buspirone | 6.18 | Standard Deviation 2.97 | counts per hour | |
| Exercise Pulmonary Capacity | Placebo | 18.28 | Standard Deviation 8.20 | ml/kg of O2 | |
| Exercise Pulmonary Capacity | Buspirone | 17.69 | Standard Deviation 7.29 | ml/kg of O2 |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline | STARTED | Placebo Then Buspirone | 5 | |
| Baseline | STARTED | Buspirone Then Placebo | 4 | |
| Baseline | COMPLETED | Placebo Then Buspirone | 4 | |
| Baseline | COMPLETED | Buspirone Then Placebo | 4 | |
| Baseline | NOT COMPLETED | Placebo Then Buspirone | 1 | |
| Baseline | NOT COMPLETED | Buspirone Then Placebo | 0 | |
| Treatment 1 (14 Days) | STARTED | Placebo Then Buspirone | 4 | |
| Treatment 1 (14 Days) | STARTED | Buspirone Then Placebo | 4 | |
| Treatment 1 (14 Days) | COMPLETED | Placebo Then Buspirone | 2 | |
| Treatment 1 (14 Days) | COMPLETED | Buspirone Then Placebo | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2
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 | Gastrointestinal distress | Gastrointestinal disorders | Buspirone | 0 | 5 | |
| other | Gastrointestinal distress | Gastrointestinal disorders | Placebo | 1 | 6 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buspirone | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Buspirone | 0 | 5 |
| Total, other adverse events | Placebo | 1 | 6 |
| Total, serious adverse events | Buspirone | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buspirone vs Placebo: deaths from any cause | Trial comparisons |
| Buspirone vs Placebo: serious adverse events | Trial comparisons |
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.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05041322
GET https://conductscience.org/api/trials/v1/NCT05041322/registered