Trial Outcomes & Findings for Continuous Positive Airway Pressure and Cardiometabolic Risk (NCT NCT01403194)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

2014-05-13

Participant Flow

11 subjects with a high probability of Obstructive Sleep Apnea (OSA) were consented, and all had a baseline blood draw. 2 subjects had a normal sleep study. 9 subjects had a polysomnogram suggestive of OSA, and were given the intervention of 3 months of Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (Bi-PAP) use.

Participant milestones

Participant milestones
Measure	CPAP/Bi-PAP Subjects will be treated with either CPAP or Bi-PAP for three months.
Overall Study STARTED	11
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	CPAP/Bi-PAP Subjects will be treated with either CPAP or Bi-PAP for three months.
Overall Study Screen Failure	2
Overall Study Lost to Follow-up	8

Baseline Characteristics

Continuous Positive Airway Pressure and Cardiometabolic Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP/Bi-PAP n=11 Participants Subjects will be treated with either CPAP or Bi-PAP for three months.
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 months

Population: Only one participant returned for the 3 month visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 months

Population: Only one participant returned for the 3 month visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 months

Population: Only one participant returned for the 3 month visit.

Outcome measures

Outcome data not reported

Adverse Events

CPAP/Bi-PAP

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. Seema Kumar

Mayo Clinic

Phone: 507-538-2724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place