TransNasal Insufflation for obstructive sleep apnoea (OSA)

Completed

• Conditions: Obstructive sleep apnoea; Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN00260427
• Lead Sponsor: Respironics, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged 21 - 65 years, either sex
2. Diagnosis of OSA with a baseline AHI between 15 and 50 events/hour of sleep
3. Able and willing to provide written informed consent
4. English speaking

Exclusion Criteria

1. Participation in another interventional research study within the last 30 days
2. Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
3. Prior PAP use or treatment for OSA, excluding split-night PAP exposure
4. Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCO2 greater than or equal to 55 mmHg)
5. Presence of untreated, non-OSA related sleep disorders, e.g., moderate to severe restless legs (Periodic Limb Movement Index [PLMI] greater than or equal to 10) or insomnia
6. Body mass index (BMI) greater than 40 kg/m^2. Most subjects will have a BMI less than or equal to 35 kg/m^2 but we will include a small subset of subjects with a BMI greater than 35 kg/m^2 but less than or equal to 40 kg/m^2.
7. Severe sleepiness (automobile accident or near accident in the last 12 months due to sleepiness)
8. Severe oxygen desaturation on the polysomnography (PSG) (oxygen saturation [Sa02] less than 70% for 10% of the diagnostic PSG study)
9. Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
10. Currently using supplemental oxygen
11. Regular use of sleeping pills or stimulants
12. Currently working night shift or rotating day/night shift

There will be no exclusion based on gender, race or ethnicity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified