Trial Outcomes & Findings for The Impact of Venlafaxine on Apnea Hypopnea Index in Obstructive Sleep Apnea (NCT NCT02714400)

NCT ID: NCT02714400

Last Updated: 2020-04-17

Results Overview

The Apnea hypopnea index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The change from baseline in apnea hypopnea index after a single dose of Venlafaxine will be evaluated using overnight polysomnography. An apnea hypopnea index less than five events per hour is considered within normal limits.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 7-day follow up
• Results posted on: 2020-04-17

Participant Flow

Participant milestones

Measure	Venlafaxine First, Placebo Second 50mg of Venlafaxine before sleep first night 1 Pill of Placebo before sleep second night	Placebo First, Venlafaxine Second 1 Pill of Placebo before sleep first night 50mg of Venlafaxine before sleep second night
First Intervention (1 Day) STARTED	12	8
First Intervention (1 Day) COMPLETED	12	8
First Intervention (1 Day) NOT COMPLETED	0	0
Washout (>4 Days) STARTED	12	8
Washout (>4 Days) COMPLETED	12	8
Washout (>4 Days) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	12	8
Second Intervention (1 Day) COMPLETED	12	8
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Venlafaxine on Apnea Hypopnea Index in Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	All Analyzed Participants n=20 Participants All participants who were randomized, completed both study nights, and were included in the analysis.
Age, Continuous	53.8 Years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7-day follow up

The Apnea hypopnea index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The change from baseline in apnea hypopnea index after a single dose of Venlafaxine will be evaluated using overnight polysomnography. An apnea hypopnea index less than five events per hour is considered within normal limits.

Outcome measures

Measure	Venlafaxine n=20 Participants 50mg of Venlafaxine before sleep Venlafaxine: Venlafaxine 50mg before sleep	Placebo n=20 Participants One piece of placebo before sleep Placebo: One piece of placebo before sleep
The Apnea Hypopnea Index	40.5 Events per Hour of Sleep Standard Deviation 16.5	46.1 Events per Hour of Sleep Standard Deviation 21.9

PRIMARY outcome

Timeframe: Baseline and 7-day follow up

Change from baseline in nadir oxygen level during sleep after a single dose of Venlafaxine will be evaluated using overnight polysomnography. A lower blood oxygen saturation during sleep is associated with a more severe obstructive sleep apnea.

Outcome measures

Measure	Venlafaxine n=20 Participants 50mg of Venlafaxine before sleep Venlafaxine: Venlafaxine 50mg before sleep	Placebo n=20 Participants One piece of placebo before sleep Placebo: One piece of placebo before sleep
Nadir Oxygen Level During Sleep	82.0 Percent Oxygen Saturation Interval 80.0 to 84.0	81.5 Percent Oxygen Saturation Interval 75.8 to 84.2

SECONDARY outcome

Timeframe: Baseline and 7-day follow up

Population: In one subject loop gain could not be quantified.

Loop gain 1 is used to describe the stability of ventilatory control. The change from baseline in loop gain after a single dose of Venlafaxine will be estimated.

Outcome measures

Measure	Venlafaxine n=19 Participants 50mg of Venlafaxine before sleep Venlafaxine: Venlafaxine 50mg before sleep	Placebo n=19 Participants One piece of placebo before sleep Placebo: One piece of placebo before sleep
Loop Gain	0.58 Dimensionless Standard Deviation 0.15	0.56 Dimensionless Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline and 7-day follow up

Population: In one subject arousal threshold could not be quantified.

Change from baseline in respiratory arousal threshold after single dose of Venlafaxine will be estimated.

Outcome measures

Measure	Venlafaxine n=19 Participants 50mg of Venlafaxine before sleep Venlafaxine: Venlafaxine 50mg before sleep	Placebo n=19 Participants One piece of placebo before sleep Placebo: One piece of placebo before sleep
Arousal Threshold	115.6 Percent V-eupnea Interval 108.2 to 130.8	118.6 Percent V-eupnea Interval 113.4 to 137.9

SECONDARY outcome

Timeframe: Baseline and 7-day follow up

Change from baseline in sleep efficiency after single dose of Venlafaxine will be estimated using overnight polysomnography.

Outcome measures

Measure	Venlafaxine n=20 Participants 50mg of Venlafaxine before sleep Venlafaxine: Venlafaxine 50mg before sleep	Placebo n=20 Participants One piece of placebo before sleep Placebo: One piece of placebo before sleep
Sleep Efficiency	63.1 Percent Time in Bed Standard Deviation 16.7	72.5 Percent Time in Bed Standard Deviation 15.5

Adverse Events

Venlafaxine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Venlafaxine n=20 participants at risk 50mg of Venlafaxine before sleep Venlafaxine: Venlafaxine 50mg before sleep	Placebo n=20 participants at risk One piece of placebo before sleep Placebo: One piece of placebo before sleep
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2	5.0% 1/20 • Number of events 1

Additional Information

Dillon Gilbertson

UCSD

Phone: 8582452155

Email: dcgilbertson@health.ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place