Obstructive Sleep Apnoea Syndrome MedDRA version: 20.0 Level: LLT Classification code 10029983 Term: Obstructive sleep apnoea syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10028735 Term: Nasal congestion System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Sudafed Congestion Relief 10ml
Product Name: Sudafed Congestion Relief 10ml
Product Code: PL 15513/0368
Pharmaceutical Form: Nasal spray
INN or Proposed INN: xylometazoline
CAS Number: 526
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial. 2. Male or Female, aged 18 years or above. 3. Diagnosed with proven obstructive sleep apnoea, with an ODI > 15 and 3 months with mean usage of > 4 hours/ night for last 3 months 5. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 6. Willing to withdraw from CPAP treatment for 28 days 7. Good mobile phone reception 8. Use of Wi-Fi at home Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 116 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
Exclusion criteria: 1. Significant renal or hepatic impairment. 2. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. 3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. 4. Participants who have participated in another research trial involving an investigational product in the past 12 weeks. 5. Professional driver or, as assessed by the local investigator, any other vigilance critical activity. 6. Daytime SaO2 6.0, significant hypoventilation on diagnostic sleep study mean saturation <92% 7. Previous or current history of central sleep apnoea or Cheyne-Stokes respiration. 8. Previous history of a sleepiness-related accident. 9. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 10. Participants with a fructose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of Xylometazoline versus placebo on the time to return of Obstructive Sleep Apnoea (OSA) in patients with mild to moderate OSA following withdrawal of CPAP therapy;Secondary Objective: To assess the effect of Xylometazoline versus placebo on subjective daytime sleepiness in patients with moderate OSA following withdrawal of CPAP therapy. To assess the effect of Xylometazoline versus placebo on sleep fragmentation in patients with moderate OSA following withdrawal of CPAP therapy. ;Primary end point(s): Comparison of the number of days to return of obstructive sleep apnoea on overnight pulse oximetry (oxygen desaturation index >15 on 3 consecutive nights) or until patient is unwilling to continue without CPAP and restarts their device. ;Timepoint(s) of evaluation of this end point: Maximum treatment duration 28 days, or sooner if overnight oximetry shows return of obstructive sleep apnoea (oxygen desaturation index >15 on 3 consecutive nights). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the effect of Xylometazoline versus placebo on subjective daytime sleepiness in patients with moderate OSA following withdrawal of CPAP therapy 2. To assess the effect of Xylometazoline versus placebo on sleep fragmentation in patients with moderate OSA following withdrawal of CPAP therapy ;Timepoint(s) of evaluation of this end point: 1. Patient reported sleepiness on Epworth Sleepiness Score at baseline, and weekly (day 0, 7, 14, 21 and 28) until 35 days 2. Overnight pulse oximetry during withdrawal of CPAP, (maximum 28 days) to assess pulse rate variability | — |
Countries
United Kingdom
Outcome results
None listed