Trial Outcomes & Findings for Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury (NCT NCT00629850)

Results Overview

Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

10 weeks

Results posted on

2019-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Powerlung Trainer Device The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.	Control This arm of the study will not receive the device.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Powerlung Trainer Device n=1 Participants The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.	Control This arm of the study will not receive the device.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: There was only one participant completing the study. No analyses performed.

Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 10 weeks

Population: there was only one participant completing this study. No analyses performed.

Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 10 weeks

Population: there was only one participant completing this study. No analyses performed.

Outcome measures

Outcome data not reported

Adverse Events

Powerlung Trainer Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Chris Russian, Associate Professor

Texas State Respiratory Care Department

Phone: 512-245-3794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place