An Exploratory Study of a Nasal Dilator Strip
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Nasal Resistance in Sleeping State : Nasal Resistance Phase
研究概览
简要总结
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.
详细描述
This study was a baseline-controlled study. This study consisted of three phases: Baseline phase, 28 days Active phase (1 month in home treatment usage period with sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment) followed by a two-night cross-over Nasal resistance phase. Screened participants were evaluated for sleep disordered breathing and PSG variables with sleep laboratory nights at Baseline, after 7 and 28 days of in house use of nasal dilator strip (Night 8 and 29 of Active phase), and at Day 30 and 31 (Night 30 and 31 of Nasal resistance phase). Participants wore the Nasal dilator strip during Active phase. Participants then entered the Nasal resistance phase of the study, which consisted of two sleep laboratory nights at Day 30 and 31 (Night 30 and 31) where they were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip" as per there randomization schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)
- •Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.
- •Sleep: Reports trouble with sleep
排除标准
- •Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.
- •Subject has a chronic skin condition or eczema on the face or nose.
- •Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.
- •Subject has severe obstructive sleep apnea/hypopnea syndrome with an AHI score <30 events/hour at the Baseline visit.
- •Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping >2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).
- •Subject has a non-typical sleep schedule (e.g. shift-work).
- •Subject plans travel involving time-zone changes during the study period.
- •Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide, hypnotics and sedatives. Use of over the counter sleep promoting agents including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava, melatonin, St John's Wort and Alluna. Use of over the counter alertness aids including caffeine and guarana.
- •Subject currently uses any topical nasal decongestants (nasal sprays, drops, etc). Subject must have discontinued use of topical decongestants at least 7 days prior Baseline.
- •Subject is experiencing an acute upper respiratory tract infection at during qualification phase and at Baseline visit.
- •Subject abuses alcohol (regularly drinks more than 3 drinks per day) or has a recent history (within last 2 years) of substance or alcohol abuse. Regular consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
- •Subject has a positive drug of abuse screening result.
- •Subject has severe, unstable disease states (e.g. myocardial infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study or who in the judgement of the principal investigator would not be suitable for entry into this study.
- •Severe nasal obstruction caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator, i.e. nasal polyps, severe deviated septum.
- •Subject is unwilling to be videotaped or recorded during the PSG studies.
- •Current Treatment for Sleep Disordered Breathing a) Subject currently uses devices prescribed for sleep disordered breathing including Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, tongue displacement devices. b)Over-the-counter products such as chin straps, pillows, internal/external nasal dilators are acceptable provided usage is discontinued at least 28 days prior to Baseline.
研究组 & 干预措施
All participants (Baseline phase)
All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1.
干预措施: Prototype nasal dilator strip (Device)
All Participants (Active Phase)
All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment
干预措施: Prototype nasal dilator strip (Device)
All Participants (Nasal Resistance Phase)
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
干预措施: Prototype nasal dilator strip (Device)
All Participants (Nasal Resistance Phase)
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
干预措施: No strip (Other)
结局指标
主要结局
Nasal Resistance in Sleeping State : Nasal Resistance Phase
时间窗: upto 2 days
Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights \[on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively\], of the nasal resistance phase.
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
时间窗: Day 1
Nasal resistance was measured on Day 1, by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities.
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
时间窗: Day 1
Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 (baseline phase) before and after Nasal dilator strip application.
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
时间窗: Day 1
Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.
次要结局
- Total Epworth Sleepiness Scale Score (ESS) : Active Phase(Day 29)
- Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase(Day 29)
- Global Self Assessment Score : Active Phase(Day 29)
- Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)
- Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase(Day 1, Day 8, Day 29, Day 30 and Day 31)