Clinical trial NCT04305964: Nasal Airway Stent (Nastent®) Study in OSA
Official title: The Use of Nasal Airway Stent (Nastent®) in Patients With Sleep-disordered Breathing (SDB) Including Snoring and/or Obstructive Sleep Apnea (OSA).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Snoring
Stent
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study intends to assess the effect of nasal airway stent (Nasten®) as a treatment modality in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA). Nastent®, a distally perforated soft silicon nasal tube, is a mechanical splint against collapse of the upper airway at multiple levels. Nastent® might be able to prevent the vibrations caused by fluttering of various parts of the upper airway which leads to snoring. Furthermore, it also potentially secures a patent airway throughout the night securing airflow.

Detailed description: Patients with an established diagnosis of OSA with apnea/hypopnea-index (AHI)\< 20/ hour sleep from the ENT department are recruited and informed about the study. After obtaining informed consent and patient inclusion, a baseline portable sleep monitoring at home using WatchPAT™300 for one night is performed. During the next visit the objective size and position of the stent is determined under direct visualization using fiberoptic nasolaryngoscopy. Subsequently, the patients will receive a Nastent® Starter kit (containing 6 different stent sizes of Nastent®, 130, 135, 140, 145, 150 and 155mm) to gradually get accustomed to the stent and to find the right size for them. During the following consultation, a Nastent® classic kit (containing 7 stents of the same size, each can be used for two consecutive nights) is given to the patients to be used for 14 consecutive nights. During the last night of this 14-night period, a follow-up home portable sleep monitoring evaluation using WatchPAT™300 is performed with Nastent® in situ. Afterwards, during the final visit at the outpatient clinic, acceptance of the therapy with Nastent® by the patients is evaluated, and the decision of whether to continue the therapy and to proceed to the purchase of this product as a long-term treatment for the patient or not, is made.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* AHI ≤ 20 per hour of sleep
* Complaints of socially disturbing snoring by the partner of the patient
* Capable of giving informed consent

Exclusion Criteria:

* Craniofacial deformities
* Acute nasal trauma, fracture (during the 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.
* Pregnancy or willing to become pregnant
* Excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs)
* History of sleep medication use

Primary outcomes:
measure: AHI (apnea-hypopnea index)
timeFrame: At baseline
measure: AHI (apnea-hypopnea index)
timeFrame: at follow up after completion of treatment period (an average of three weeks)
Secondary outcomes:
measure: Epworth sleepiness scale score (ESS)
timeFrame: baseline
measure: VAS (visual analogue scale) for snoring
timeFrame: Baseline
measure: ODI (oxygen desaturation index)
timeFrame: baseline
measure: PAT (peripheral arterial tone) signal
timeFrame: baseline
measure: Heart rate
timeFrame: baseline
measure: Body position
timeFrame: baseline
measure: Snoring
timeFrame: baseline
measure: Oxygen saturation (SaO2)
timeFrame: baseline
measure: RDI (Respiratory disturbance index)
timeFrame: baseline
measure: Sleep/wake state
timeFrame: baseline
measure: REM sleep
timeFrame: baseline
measure: Deep sleep
timeFrame: baseline
measure: Light sleep
timeFrame: baseline
measure: Sleep latency
timeFrame: baseline
measure: REM latency
timeFrame: baseline
measure: Total sleep time
timeFrame: baseline
measure: Epworth sleepiness scale score (ESS)
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: VAS (visual analogue scale) for snoring
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: ODI (oxygen desaturation index)
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: PAT (peripheral arterial tone) signal
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Heart rate
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Body position
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Snoring
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Oxygen saturation (SaO2)
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: RDI (Respiratory disturbance index)
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Sleep/wake state
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: REM sleep
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Deep sleep
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Light sleep
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Sleep latency
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: REM latency
timeFrame: at follow up after completion of treatment period (an average of three weeks)
measure: Total sleep time
timeFrame: at follow up after completion of treatment period (an average of three weeks)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: Head of ENT department, UZA
name: Olivier Vanderveken, MD, PhD
role: STUDY_CHAIR
References:
citation: Okuno K, Ono Minagi H, Ikai K, Matsumura Ai E, Takai E, Fukatsu H, Uchida Y, Sakai T. The efficacy of nasal airway stent (Nastent) on obstructive sleep apnoea and prediction of treatment outcomes. J Oral Rehabil. 2019 Jan;46(1):51-57. doi: 10.1111/joor.12725. Epub 2018 Oct 21.
citation: Kumar AR, Guilleminault C, Certal V, Li D, Capasso R, Camacho M. Nasopharyngeal airway stenting devices for obstructive sleep apnoea: a systematic review and meta-analysis. J Laryngol Otol. 2015 Jan;129(1):2-10. doi: 10.1017/S0022215114003119. Epub 2014 Dec 29.