Trial Outcomes & Findings for Remote Monitoring in Obstructive Sleep Apnea (NCT NCT01678560)

NCT ID: NCT01678560

Last Updated: 2019-12-11

Results Overview

Positive Airway Pressure Treatment Adherence defined as mean PAP use being \> 4 hours per night for greater than 70% of nights.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: First 3 months
• Results posted on: 2019-12-11

Participant Flow

Participant milestones

Measure	Usual Care These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Overall Study STARTED	26	26
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	Usual Care These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Overall Study Physician Decision	4	4
Overall Study Death	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Remote Monitoring in Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	Usual Care n=26 Participants These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=26 Participants These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring	Total n=52 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	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: First 3 months

Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.

Outcome measures

Measure	Usual Care n=22 Participants These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=20 Participants These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months	10 Participants	9 Participants

PRIMARY outcome

Timeframe: 4-12 Months

Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being > 4 hours per night for greater than 70% of nights

Outcome measures

Measure	Usual Care n=22 Participants These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=20 Participants These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 1 subject from the Wireless group was assigned to Provent treatment. 1 subject from the Usual group was assigned to Dental device treatment. Both subjects stopped using PAP and PAP monitoring and were considered not receiving effective PAP treatment for obstructive sleep apnea. Both subjects were lost in follow-up for our research study.

Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.

Outcome measures

Measure	Usual Care n=22 Participants These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=20 Participants These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Receiving Effective Treatment for Obstructive Sleep Apnea	10 Participants	10 Participants

POST_HOC outcome

Timeframe: 12 months

PAP treatment Adherence in the first 3 months of treatment (according to the CMS - Centers for Medicare & Medicaid Services - criteria) was compared to the PAP treatment Adherence in the next 9 months of treatment to verify the predictability of initial adherence or non-adherence for the future adherence or non-adherence (during the year) to PAP treatment. Adherence/non-adherence was analyzed based on the PAP usage reports (downloads) from the supplied PAP device, based on the yearly, quarterly and monthly portions of the reports.

Patient data representing initial adherence or non-adherence and adherence or non-adherence during the year to PAP treatment was collected across both Usual care and Wireless Care Arms.

Outcome measures

Measure	Usual Care n=19 Participants These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=23 Participants These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
PAP Treatment Adherence in the First 3 Months of Treatment Compared to the PAP Treatment Adherence in the Next 9 Months of Treatment Adherent in the next 9 months	13 Participants	7 Participants
PAP Treatment Adherence in the First 3 Months of Treatment Compared to the PAP Treatment Adherence in the Next 9 Months of Treatment Non-Adherent in the next 9 months	6 Participants	16 Participants

POST_HOC outcome

Timeframe: 1 year/12 months

PAP adherence in subjects who had more than 20 respiratory events per hour during the initial sleep study was compared with the PAP adherence in subjects who had less than 20 respiratory events per hour during the initial sleep study.Patient data representing subjects who had more than 20 respiratory events per hour during the initial sleep study and subjects who had less than 20 respiratory events per hour during the initial sleep study was collected across both Usual care and Wireless Care Arms.

Outcome measures

Measure	Usual Care n=23 Participants These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=19 Participants These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Adherence and AHI Adherent in 12 months	19 Participants	7 Participants
Adherence and AHI ANon-Adherent in 12 months	4 Participants	12 Participants

Adverse Events

Usual Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Wireless Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Usual Care n=26 participants at risk These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals. Monitoring every 3 months by face-to-face visits	Wireless Care n=26 participants at risk These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data. Frequent remote monitoring
Psychiatric disorders Acute Inpatient Psychiatric hospitalization	0.00% 0/26 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.	3.8% 1/26 • Number of events 1 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.
Cardiac disorders Wolf -Parkinson-White syndrome. Hospitalization	3.8% 1/26 • Number of events 1 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.	0.00% 0/26 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.
Cardiac disorders Hospitalisation due to Dyspnea and Chest Pain on exertion	3.8% 1/26 • Number of events 1 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.	0.00% 0/26 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization of encephalopathic patient transitioned to comfort care	0.00% 0/26 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.	3.8% 1/26 • Number of events 1 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.
Surgical and medical procedures Hospitalization Elective Laparoscopic repair of incisional hernia	3.8% 1/26 • Number of events 1 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.	0.00% 0/26 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.
Surgical and medical procedures Hospitalization for Elective Laminectomy - Fusion	0.00% 0/26 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.	3.8% 1/26 • Number of events 1 • Adverse event data were collected over a period of time of subjects' participation in the study - 1 year or until a subject was withdrawn or terminated from the study The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov Definitions. Data was collected during the subject's follow-up and from the medical chart review.

Other adverse events

Adverse event data not reported

Additional Information

Meir Kryger, MD

Yale University

Phone: 203-815-0914

Email: meir.kryger@yale.edu

Results disclosure agreements

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