TranQuill™ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea:
Palavras-chave
Resumo
Descrição
Study Methodology:
Subject Recruitment. Twenty subjects will be recruited from the MUSC Snoring Clinics as well as public information seminars held in the greater Charleston area. Attempts will be made to recruit both a gender and racially diverse study population.
Subject Screening. Subjects who are potentially eligible for the trial include patients who seek treatment chronic snoring disruptive to their bed-partner. Patients will require a pre-treatment assessment with a Watch-PAT home sleep study device to rule-out moderate and severe sleep apnea. Patients must have a regular bed-partner to participate in order to capture study outcomes.
Inclusion Criteria. Potential subjects must meet the following inclusion criteria:
- Age ≥ 22 years (no upper limit)
- Regular bed-partner
- Chronic, disruptive snoring according to bed-partner
- Snoring, upper airway resistance syndrome, or mild obstructive sleep apnea (AHI ≤ 15; lowest O2 saturation ≥ 85%) on home sleep testing with Watch-PAT
- No prior surgical treatment for snoring or OSAS other than nasal surgery
- Willing and capable of providing informed consent
Exclusion Criteria.
- Age < 22 years
- No regular bed-partner
- Intermittent or occasional snoring
- Moderate-to-severe obstructive sleep apnea (AHI ≥ 16; Lowest O2 sat <85%) or evidence of central apnea (≥ 10% of apneic events) on home sleep testing with Watch-PAT
- BMI ≥ 32 kg/m2
- Modified Mallampati 3 or 4
- Tonsil Grade 3 or 4
- Significant nasal obstruction (> 50% of nasal airway diameter on one side)
- Previous palatal surgery (cleft palate; uvulopalatopharyngoplasty; uvulectomy; Pillar implants; Somnoplasty)
- Current cigarette smoker (≥ 1 cigarette per day)
- Known history of coronary artery disease or stroke
- Chronic obstructive pulmonary disease (COPD)
- Diabetes
- Major depression or non-controlled psychiatric illness
- Drug or alcohol abuse
- Untreated or poorly controlled hypertension
- Anticoagulation therapy (ex. Coumadin or Plavix; single baby aspirin per day allowable)
- History of bleeding or clotting disorder
- Another significant sleep disorder (e.g., insomnia, periodic limb movement)
- Tonsillar hypertrophy
- Chronic Obstructive Pulmonary Disease (COPD)
- Interstitial Lung Disease (ILD)
- Cystic Fibrosis
- Acute Repiratory Distress Syndrome (ARDS)
- Nasal or supraglottic obstruction on fiberoptic examination
- ASA class III ,IV, V
- Latex allergy
- Lidocaine allergy
- Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment and/or be using an acceptable form of birth control (OCPs; IUD).
- Major depression or non-stabilized psychiatric disorder
- Drug or alcohol abuse
- Previous palatal or tongue surgery
- Stable or unstable angina
- CHF
- Moderate or severe valvular disease
- TIA/CVA
- Carotid stenosis or endarterectomy
- Anemia
- Room air SpO2 < 95%
- Pulmonary hypertension
- Dialysis
- Central or mixed apnea ≥ 10% of respiratory events
- Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study
datas
| Última verificação: | 08/31/2018 |
| Enviado pela primeira vez: | 04/14/2014 |
| Inscrição estimada enviada: | 02/09/2015 |
| Postado pela primeira vez: | 02/17/2015 |
| Última atualização enviada: | 09/05/2018 |
| Última atualização postada: | 09/09/2018 |
| Data real de início do estudo: | 01/31/2014 |
| Data Estimada de Conclusão Primária: | 07/31/2014 |
| Data Estimada de Conclusão do Estudo: | 07/31/2014 |
Condição ou doença
Intervenção / tratamento
Procedure: Snoreplasty
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Snoreplasty Treatment of Snoring and/or mild obstructive sleep apnea with snoreplasty. | Procedure: Snoreplasty The procedure will be performed under local anesthesia in the examination chair. The subject's throat will be anesthetized with benzocaine spray followed by infiltration of the soft palate with 4-5 milliliters of 1% lidocaine with 1:100,000 epinephrine. The TranQuill suture will be inserted into the soft palate tissues using a predescribed pattern. |
Critério de eleição
| Idades qualificadas para estudar | 22 Years Para 22 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Age ≥ 22 years (no upper limit) - Regular bed-partner - Chronic, disruptive snoring according to bed-partner - Snoring, upper airway resistance syndrome, or mild obstructive sleep apnea (AHI ≤ 15; lowest O2 saturation ≥ 85%) on home sleep testing with Watch-PAT - No prior surgical treatment for snoring or OSAS other than nasal surgery - Willing and capable of providing informed consent Exclusion Criteria: - Age < 22 years - No regular bed-partner - Intermittent or occasional snoring - Moderate-to-severe obstructive sleep apnea (AHI ≥ 16; Lowest O2 sat <85%) or evidence of central apnea (≥ 10% of apneic events) on home sleep testing with Watch-PAT - BMI ≥ 32 kg/m2 - Modified Mallampati 3 or 4 - Tonsil Grade 3 or 4 - Significant nasal obstruction (> 50% of nasal airway diameter on one side) - Previous palatal surgery (cleft palate; uvulopalatopharyngoplasty; uvulectomy; Pillar implants; Somnoplasty) - Current cigarette smoker (≥ 1 cigarette per day) - Known history of coronary artery disease or stroke - Chronic obstructive pulmonary disease (COPD) - Diabetes - Major depression or non-controlled psychiatric illness - Drug or alcohol abuse - Untreated or poorly controlled hypertension - Anticoagulation therapy (ex. Coumadin or Plavix; single baby aspirin per day allowable) - History of bleeding or clotting disorder - Another significant sleep disorder (e.g., insomnia, periodic limb movement) - Tonsillar hypertrophy - Chronic Obstructive Pulmonary Disease (COPD) - Interstitial Lung Disease (ILD) - Cystic Fibrosis - Acute Repiratory Distress Syndrome (ARDS) - Nasal or supraglottic obstruction on fiberoptic examination - ASA class III ,IV, V - Latex allergy - Lidocaine allergy - Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment and/or be using an acceptable form of birth control (OCPs; IUD). - Major depression or non-stabilized psychiatric disorder - Drug or alcohol abuse - Previous palatal or tongue surgery - Stable or unstable angina - CHF - Moderate or severe valvular disease - TIA/CVA - Carotid stenosis or endarterectomy - Anemia - Room air SpO2 < 95% - Pulmonary hypertension - Dialysis - Central or mixed apnea ≥ 10% of respiratory events - Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study |
Resultado
Medidas de Resultado Primário
1. Apnea-Hypopnea Index [90 days]
2. Oxygen Desaturation Index [90 days]
3. Respiratory Disturbance Index [90 days]
4. Bed Partner Scoring [90 days]
