Trial Outcomes & Findings for Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury (NCT NCT01882257)

NCT ID: NCT01882257

Last Updated: 2017-01-11

Results Overview

After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: Month 4 after enrollment
• Results posted on: 2017-01-11

Participant Flow

93 subjects were enrolled in the study. 2 subjects were found to be ineligible due to level of spinal cord injury. 91 patients remained in the study and were asked to keep daily logs of symptoms. 17 subjects were unable or unwilling to come to the first study visit.

Participant milestones

Measure	Normal Sleep Breathing Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.	BiPAP -Auto for Sleep Apnea Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea.	BiPAP (AVAPS) for Nocturnal Hypoventilation Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation. BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder.
Study Origination to Beginning Therapy STARTED	11	40	23
Study Origination to Beginning Therapy Started Therapy Using Device	11	38	22
Study Origination to Beginning Therapy COMPLETED	11	38	22
Study Origination to Beginning Therapy NOT COMPLETED	0	2	1
Therapy Portion of Study (12 Months) STARTED	11	38	22
Therapy Portion of Study (12 Months) COMPLETED	11	27	18
Therapy Portion of Study (12 Months) NOT COMPLETED	0	11	4

Reasons for withdrawal

Measure	Normal Sleep Breathing Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.	BiPAP -Auto for Sleep Apnea Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea.	BiPAP (AVAPS) for Nocturnal Hypoventilation Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation. BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder.
Study Origination to Beginning Therapy Withdrawal by Subject	0	2	1
Therapy Portion of Study (12 Months) Withdrawal by Subject	0	11	4

Baseline Characteristics

Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury

Baseline characteristics by cohort

Measure	Normal Sleep Breathing n=11 Participants Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.	BiPAP -Auto for Sleep Apnea n=40 Participants Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea.	BiPAP (AVAPS) for Nocturnal Hypoventilation n=23 Participants Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation. BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder.	Total n=74 Participants Total of all reporting groups
Age, Customized 18 to 75 years	11 participants n=5 Participants	40 participants n=7 Participants	23 participants n=5 Participants	74 participants n=4 Participants
Gender Female	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Gender Male	9 Participants n=5 Participants	35 Participants n=7 Participants	20 Participants n=5 Participants	64 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	40 participants n=7 Participants	23 participants n=5 Participants	74 participants n=4 Participants

PRIMARY outcome

Timeframe: Month 4 after enrollment

After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.

Outcome measures

Measure	Entire Tested Population n=74 Participants All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults Sleep disordered breathing without hypercapnia	40 participants
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults Sleep-disordered breathing with hypercapnia	23 participants
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults Normal sleep breathing	11 participants

PRIMARY outcome

Timeframe: Overnight testing (4-13 hours)

All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).

Outcome measures

Measure	Entire Tested Population n=74 Participants All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
The Frequency of Technical Errors Related to the Home-based Overnight Testing. Transcutaneous pCO2/SpO2 Monitor	9 participants
The Frequency of Technical Errors Related to the Home-based Overnight Testing. HSAT (Home Sleep Apnea Test)	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0-16 after enrollment

The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 4-16

At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 4-16

When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 4 after enrollment

Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.

Outcome measures

Outcome data not reported

Adverse Events

Normal Sleep Breathing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BiPAP -Auto for Sleep Apnea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BiPAP (AVAPS) for Nocturnal Hypoventilation

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

Robert G. Sitrin, M.D.

University of Michigan Health System

Phone: (734) 936-5201

Email: rsitrin@umich.edu

Results disclosure agreements

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