| Primary | Nasal Resistance in Sleeping State : Nasal Resistance Phase | 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. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number of participants analyzed "N" signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for the specified categories. | Posted | | Mean | Standard Deviation | Centimeter (cm) H2O/liter/sec | | upto 2 days | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| | | Title | Denominators | Categories |
|---|
| Without strip (Day 30 and 31) | | | | With strip (Day 30 and 31) | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.0147 | p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment & period as fixed effects, participants as random effects & time as repeated measures effect. | | | | | | 95 | | | | | | | Superiority | | |
|
| Primary | Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase | 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. | Safety population included all participants to whom the study treatment was dispensed. Here, "N" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cm^2 | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants (Baseline Phase) | All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1 |
| |
| Primary | Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase | 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. | Safety population included all participants to whom the study treatment was dispensed. Here, "N" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cm^3 | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants (Baseline Phase) | All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1 |
| |
| Primary | Nasal Resistance by Posterior Rhinomanometry : Baseline Phase | 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. | Safety population included all participants to whom the study treatment was dispensed. Here, "N" signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for the specified categories. | Posted | | Mean | Standard Deviation | cmH2O/liter/seconds | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants (Baseline Phase) | All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1 |
| |
| Secondary | Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase | The FOSQ was 30-item, validated psychometric instrument that assessed the impact of disorders of excessive sleepiness on functional outcomes relevant to daily behaviors and quality of life (QoL). The responses to the questionnaire were grouped according to five factors for analysis: 1) Activity Level, 2) Vigilance, 3) Intimacy and Sexual Relationships, 4) General Productivity and 5) Social Outcome. Participant used a scale of 0 to 4 to score each question of FOSQ which then grouped in above factors (where 0= I don't do this activity for other reasons, 1= Yes, extreme difficulty, 2= Yes, moderate difficulty, 3= Yes, a little difficulty, and 4= No difficulty). Total score of composite FOSQ was the sum of scores obtained on all 30 questions of the questionnaire. The possible range for the total score of composite FOSQ was from 0-120. A higher total score of composite FOSQ indicates better QoL of the participant. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, "N" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| Secondary | Global Self Assessment Score : Active Phase | On Day 29, prior to sleep, participants were asked to rate their overall experience with the strip as compared to before they enrolled in the study: ease of breathing, staying asleep, falling back to sleep, waking up too early, number of awakenings, falling asleep, sleep quality, sleep depth, dry mouth upon awakening, morning headache, nocturia (waking up to urinate), feeling refreshed in the morning. Experience was rated on scale of -2 to 2 were: -2 = Much worse, -1 = Somewhat worse, 0 = No change, 1 = Somewhat improve, 2 = Much improved (higher score indicated improvement). | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable for the specified categories. | Posted | | Mean | Standard Deviation | Score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| Secondary | Total Epworth Sleepiness Scale Score (ESS) : Active Phase | Participants answered the following question How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 1. Sitting and reading, 2. Watching TV, 3. Sitting, inactive in a public place (e.g. a theatre or a meeting), 4. As a passenger in a car for an hour without a break, 5. Lying down to rest in the afternoon when circumstances permit, 6. Sitting and talking to someone, 7. Sitting quietly after a lunch without alcohol, and 8. In a car, while stopped for a few minutes in the traffic. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. Total ESS was calculated as the sum of all the individual scores observed for the above mentioned situations. The possible range for total ESS was 0-24. A lower total ESS indicates better sleep. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, "N" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Score on scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| Secondary | Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase | The Investigator or designee recorded the number of snores per hour during the participant's domiciled sleep visits. Numbers of snores were recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints | Posted | | Mean | Standard Deviation | Number of snores per hour | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase | The Investigator or designee recorded the snoring percent (%) present in sleep time during the participant's domiciled sleep visits. Snoring % was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of sleep time | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase | The Investigator or designee recorded the average snore sound intensity during the participant's domiciled sleep visits. Average snore sound intensity was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Decibels | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase | The Investigator or designee recorded the peak snore sound intensity during the participant's domiciled sleep visits. Peak snore sound intensity was recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints | Posted | | Mean | Standard Deviation | Decibels | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | This was a baseline-controlled study and consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants were applied nasal dilator strip during the sleep laboratory night on Day 1 (Night 1). During the 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, Night 8) and 28 days (Day 29, Night 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 Night 30 and Day 31 Night 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase | The Investigator or designee recorded the Nasal breathing route during the participant's domiciled sleep visits. Nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of participants | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase | The Investigator or designee recorded the oro-nasal breathing route during the participant's domiciled sleep visits. Oro-nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of participants | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase | TST was measured by overnight polysomnography (PSG) using a computerized system. TST was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Minutes | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase | Sleep efficiency [SE, a polysomnography (PSG)] was measured as the percentage of total time in bed spent in sleep. It was calculated as the sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. SE gives an overall sense of how well the participant slept and was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of sleep time | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
|
| Secondary | Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase | Sleep onset latency (SOL, a PSG parameter) was measured as the duration from the time when lights were turned off (as the participants attempted to sleep) till the time participant fell asleep. Determination of sleep and awake state was based on Electroencephalography (EEG) and behavioral parameters change. SOL was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Minutes | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
|
| Secondary | Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase | Arousal index (AI) is the number of arousals and awakenings, reported as a total number per hour of sleep. AI was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Number of arousals per hour | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase | Non-Rapid eye movement (NREM) sleep stage consist of 3 progressively deeper stages of sleep: N1 (transition period from being awake to falling asleep), N2 (where breathing and heart rate began to slow) and N3 (slow wave sleep where body heals and repair itself). Sleep architecture (SA) was measured by the percentage of sleep time spent by the participants in each stage (time spent in each stage to total time spent in NREM, multiplied by 100). SA was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of sleep time | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
|
| Secondary | Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase | Total NREM (N1, 2, and 3) and REM sleep were calculated as the time spent by a participant in the NREM (measured during stable sleep) and REM sleep stages. Total NREM and REM sleep was measured by overnight PSG using a computerized system for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Minutes | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase | Respiratory Effort Related Arousal (RERA) was flattening of an inspiratory portion of nasal pressure with increased respiratory effort leading to arousal. The total number of arousals per hour were calculated as RERA. RERA was measured all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | RERA per hour | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | 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 | Arterial oxygen saturation (SAO2) is the fraction of [oxygen]-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. SAO2 in NREM and REM sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Lowest SAO2 values observed during the NREM and REM sleep were recorded for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of SAO2 | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
|
| Secondary | Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase | SAO2 in sleep time was measured overnight by pulse oximetry with a finger probe using a computerized system. Mean of the observed SAO2 values during entire sleep time was reported for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of SAO2 | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase | Oxygen desaturation is the drop in blood's oxygen level per hours of sleep. Average drop in oxygen level during total sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of oxygen desaturation | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase | Percent sleep time with SAO2 greater than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of sleep time | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase | Percent sleep time with SAO2 less than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of sleep time | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |
| Secondary | Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase | Apnea/Hypopnea Index (AHI) was measured as the number of events (apnea and hypopnea) per hour of sleep. AHI was measured using overnight by PSG using a computerized system. PSG was performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase. | Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | AHI events per hour | | Day 1, Day 8, Day 29, Day 30 and Day 31 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule |
| |