N/A
Completed N=36
Validation of Safety and Efficacy for Night Shift Therapy
Source: ClinicalTrials.gov NCT02032706 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events — 100 Percentage of participants
Summary
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events |
100 | — |
| PRIMARY Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy |
83 | — |
| SECONDARY Confirmation That Night Shift Accurately Detects Supine Position |
91; 93 | — |
| SECONDARY Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant |
96 | — |
| SECONDARY Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback |
97 | — |
| SECONDARY Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA |
50 | — |
| SECONDARY Evaluate Impact of Positional Therapy on Quality of Life Scores |
57 | — |
| SECONDARY Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake |
88.7; 91.3; 55.0; 61.2 | — |
| SECONDARY Assess the Accuracy of Night Shift's Measurement of Total Sleep Time |
98 | — |
| SECONDARY Assess the Accuracy of Night Shift Measurement of Sleep Efficiency |
92 | — |
Eligibility Criteria
The inclusion criteria are:
- be between the age of 18 and 75 years,
- have been diagnosed with Obstructive Sleep Apnea (OSA) during polysomnography at a designated sleep center within 4 months of their enrollment,
- have not received treatment with any OSA therapy for more than 3 days within the past month,
- have an overall Apnea-Hypopnea Index (AHI) > 10 and hypopneas requiring >3% oxygen desaturation,
- having a non-supine Apnea-Hypopnea Index (AHI) 1.5,
- had an Epworth Sleepiness Score of 5 or more at the time of diagnosis and at the start of therapy,
- Change in weight of no more than 5 pounds since the diagnostic PSG
- access to a computer and the Internet
- sleep is sometime between 8 P.M. to 9 A.M. Monday through Friday in the same bed
Exclusion Criteria
- Neck, back or should pain which would impact ability to sleep laterally each night
- Body mass index > 35
- suffering from neurological disorders which result in ticks or tremors
- diagnosed with congestive heart failure or chronic obstructive pulmonary disease
- suffered from a stroke within the previous 12 months
- taking or planning to take narcotic medications
- unfamiliar with use of internet browsers
- travel (i.e., foreign or cruise ship) which would limit internet or mail access
- planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications
Data sourced from ClinicalTrials.gov (NCT02032706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.