Trial Outcomes & Findings for The Effects of Trazodone on Sleep Apnea Severity (NCT NCT01817907)

Last Updated: 2017-02-24

Results Overview

The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Participants will be assessed on 2 nights over an average period of 2 weeks.

Results posted on

2017-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First Subjects will receive a sugar pill (placebo) during their first sleep study night and will receive a pill of trazodone (100 mg) during their second sleep study night.	Trazodone First Subjects will receive a pill of trazodone (100 mg) during their first sleep study night and will receive a sugar pill (placebo) during their second sleep study night.
First Intervention STARTED	8	7
First Intervention COMPLETED	8	7
First Intervention NOT COMPLETED	0	0
Washout Period STARTED	8	7
Washout Period COMPLETED	8	7
Washout Period NOT COMPLETED	0	0
Second Intervention STARTED	8	7
Second Intervention COMPLETED	8	7
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Trazodone on Sleep Apnea Severity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo First n=8 Participants Subjects will receive a sugar pill during their placebo night sleep study. Placebo pill: Subjects will receive a sugar pill during the placebo arm	Trazodone First n=7 Participants Subjects will receive trazodone during their treatment night sleep study Trazodone: Subjects will receive trazodone during one of their treatment arm studies	Total n=15 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 7 • n=93 Participants	53 years STANDARD_DEVIATION 14 • n=4 Participants	53 years STANDARD_DEVIATION 10 • n=27 Participants
Gender Female	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Gender Male	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment United States	8 participants n=93 Participants	7 participants n=4 Participants	15 participants n=27 Participants

PRIMARY outcome

Timeframe: Participants will be assessed on 2 nights over an average period of 2 weeks.

Population: two subjects were excluded from analysis because of excessive number of artifacts

The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Subjects will receive a sugar pill during their placebo night sleep study. Placebo pill: Subjects will receive a sugar pill during the placebo arm	Trazodone n=13 Participants Subjects will receive trazodone during their treatment night sleep study Trazodone: Subjects will receive trazodone during one of their treatment arm studies
Apnea-Hypopnea Index	38.7 events/hour Standard Error 6.2	28.5 events/hour Standard Error 5.6

SECONDARY outcome

Timeframe: Participants will be assessed on 2 nights over an average period of 2 weeks.

Population: two subjects were excluded from analysis because of excessive number of artifacts

Subjects will have an epiglottic pressure catheter placed during their sleep studies. We will use the swing in the epiglottic pressure trace just prior to arousal to calculate the respiratory drive stimulus that is associated with an a respiratory induced arousal.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Subjects will receive a sugar pill during their placebo night sleep study. Placebo pill: Subjects will receive a sugar pill during the placebo arm	Trazodone n=13 Participants Subjects will receive trazodone during their treatment night sleep study Trazodone: Subjects will receive trazodone during one of their treatment arm studies
Arousal Threshold (cmH2O)	-19.3 cmH2O Standard Deviation 3.9	-20.3 cmH2O Standard Deviation 3.7

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Trazodone

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

D. Andrew Wellman

Brigham and women's Hospital

Phone: 617-732-8483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place