Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wallace H Coulter Center for Translational Research | OTHER |
Not provided
Not provided
This long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151).
During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). At 12 months, participants will complete sleep questionnaires as part of this long-term follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasopharyngeal airway device | Experimental | A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for two years at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device | Device | The NPA-OSA is a flexible, medical-grade silicone, tube-like device that is self-inserted into the user's nasopharyngeal airway through one nostril prior to sleep and worn throughout the night to reduce or alleviate snoring and obstructive sleep apnea. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of apnea hypopnea index (AHI) | The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. | Baseline (day 0), 24 months |
Not provided
Not provided
Inclusion Criteria:
-Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahra Nourmohammadi, PhD | Contact | 734 936-9816 | znourmoh@med.umich.edu | |
| Louise M O'Brien, PhD | Contact | 734 647-9064 | louiseo@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Louise M O'Brien, PhD | University of Michigan | Principal Investigator |
| David Zopf, MD, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |