Trial Outcomes & Findings for Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep (NCT NCT03148899)
NCT ID: NCT03148899
Last Updated: 2023-01-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Assessed on Visit 1- Day 1, Visit 2- Day 29
Results posted on
2023-01-31
Participant Flow
36 subjects with OSA were assessed for eligibility and willingness to participate in this double blinded cross over placebo-controlled trial. Four subjects declined to participate. The remaining 32 subjects were randomly assigned to receive either placebo (n=16) or oxytocin (n=16) in the first visit, then a washout period within 4 weeks, then the other intervention they did not receive in the second visit.
Participant milestones
| Measure |
Experimental: Oxytocin, Then Placebo
At visit 1 (PSG 1) subjects first will receive Oxytocin Intranasal Spray (40 IU).
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Then, at visit 2 (PSG 2), after a washout period of up to 4 weeks, they then received the Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
Subjects were blinded as to which drug they received first.
|
Experimental: Placebo, Then Oxytocin
At visit 1 (PSG 1) subjects first will receive the Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
Then, at visit 2 (PSG 2), after a washout period of up to 4 weeks, they then received the receive Oxytocin Intranasal Spray (40 IU).
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Subjects were blinded as to which drug they received first.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oxytocin, Then Placebo
n=16 Participants
At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
Placebo, Then Oxytocin
n=16 Participants
At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
16 Participants
n=16 Participants
|
32 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 9.1 • n=16 Participants
|
42.8 years
STANDARD_DEVIATION 9.1 • n=16 Participants
|
42.8 years
STANDARD_DEVIATION 9.1 • n=32 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=16 Participants
|
7 Participants
n=16 Participants
|
14 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=16 Participants
|
9 Participants
n=16 Participants
|
18 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
|
Body-mass Index
|
31.8 kg/m^2
STANDARD_DEVIATION 8.7 • n=16 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 8.7 • n=16 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 8.7 • n=32 Participants
|
PRIMARY outcome
Timeframe: Assessed on Visit 1- Day 1, Visit 2- Day 29Outcome measures
| Measure |
Oxytocin
n=19 Participants
At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
Placebo
n=19 Participants
At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
|---|---|---|
|
Duration of Obstructive Events
|
22.72 seconds
Standard Deviation 4.59
|
24.66 seconds
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Assessed on Visit 1- Day 1, Visit 2- Day 29Outcome measures
| Measure |
Oxytocin
n=19 Participants
At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
Placebo
n=19 Participants
At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
|---|---|---|
|
Respiratory Rate
|
17.39 breaths per minute
Standard Deviation 3.50
|
16.69 breaths per minute
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: Assessed on Visit 1- Day 1, Visit 2- Day 29Event-associated bradycardias were identified as a heart rate reduction of 5 bpm or more from the average heart rate during the 5 s preceding an event to the lowest heart rate either during an event or within 5 s immediately after an event. Incidence proportion, or risk, of bradycardia was calculated as follows: the number of events that resulted in bradycardia divided by the total number of events. This analysis was done using custom MATLAB (MathWorks) code to study heart rate and peripheral capillary oxyhemoglobin saturation (SPO2) before and after apnea and hypopnea events.
Outcome measures
| Measure |
Oxytocin
n=19 Participants
At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
Placebo
n=19 Participants
At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
|---|---|---|
|
Incidence Proportion of Bradycardia
|
0.08 proportion of events
Standard Deviation 0.07
|
0.14 proportion of events
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Assessed on Visit 1- Day 1, Visit 2- Day 29Outcome measures
| Measure |
Oxytocin
n=19 Participants
At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
|
Placebo
n=19 Participants
At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
Oxytocin Intranasal Spray: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
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|---|---|---|
|
O2 Minimum
|
94.31 % of Oxygen Saturation
Standard Deviation 1.80
|
92.44 % of Oxygen Saturation
Standard Deviation 4.24
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Dr. Vivek Jain
Medical Faculty Associates at The George Washington University
Phone: 202-741-2676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place