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Clinical Trials/NL-OMON50116
NL-OMON50116
Withdrawn
Not Applicable

The use of nasal airway stent (Nastent R) in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA). - NASTENT trial

astent, inc0 sites30 target enrollmentTBD
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Conditionsobstructief slaapapneuSleep apneaSnoring

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
obstructief slaapapneu
Sponsor
astent, inc
Enrollment
30
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
astent, inc

Eligibility Criteria

Inclusion Criteria

  • •AHI \< 20 per hour of sleep
  • •Complaints of socially disturbing snoring by partner
  • •Capable of giving informed consent

Exclusion Criteria

  • •\- Craniofacial deformities
  • •\- Acute nasal trauma, fracture (during past 3 months)
  • •\- Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis,
  • •recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis
  • •\- Cerebrospinal fluid leaks
  • •\- History of past or current psychiatric disorders (psychotic illness, major
  • •depression, or acute anxiety attacks as mentioned by the patient), intellectual
  • •disability, memory disorders, seizure disorders, neuromuscular disorders,
  • •cardiovascular diseases, coagulopathies (thrombocytopenia\< 100/µl), lower
  • •respiratory tract disorders.

Outcomes

Primary Outcomes

Not specified

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