Trial Outcomes & Findings for Buspirone as a Potential Treatment for Recurrent Central Apnea (NCT NCT00746954)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Overnight polysomnogram over 3 separate nights

Results posted on

2016-03-14

Participant Flow

Patients were recruited from the VA.

The HF population has psychiatric co-morbidity and often is empirically treated with antidepressants. We screened \>1000 records but enrolled and completed 8 patients, before running out of resources.

Participant milestones

Participant milestones
Measure	Arm 1 Control to ACET to BUS Each patient will act as their own control, with comparisons over three nights, this is placebo	Arm 2 Acet to Placebo to Bus Each patient will act as their own control, with comparisons over three nights, each night given actetazolamide (Acet 250mg), or placebo or buspirone (Bus 20mg),	Arm 3 BUS to ACET to PLA Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
Overall Study STARTED	3	3	2
Overall Study COMPLETED	3	3	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buspirone as a Potential Treatment for Recurrent Central Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=8 Participants Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 6.2 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Region of Enrollment United States	8 participants n=99 Participants

PRIMARY outcome

Timeframe: Overnight polysomnogram over 3 separate nights

Population: Comparisons among Drugs (not Arms)

Outcome measures

Outcome measures
Measure	BUSPIRONE n=8 Participants Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo	ACETAZOLAMIDE n=8 Participants Each patient will act as their own control, with comparisons over three nights	PLACEBO n=8 Participants Each patient will act as their own control, with comparisons over three nights
Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)	32.5 APNEA-HYPOPNEA/HR by drug or placebo Standard Deviation 5	31.2 APNEA-HYPOPNEA/HR by drug or placebo Standard Deviation 4.9	35.7 APNEA-HYPOPNEA/HR by drug or placebo Standard Deviation 8

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kingman P. Strohl MD

Louis Stokes DVA Medical Center

Phone: 216-7913800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place