Obstructive sleep apnoea Nervous System Diseases Sleep disorders
Conditions
Interventions
This is a within-subjects study of the efficacy of TNI at reducing sleep disordered breathing (SDB) in participants with newly diagnosed sleep apnoea. Thirty participants with diagnosed OSA will be re
Sponsors
Respironics, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are four primary dependent variables for this study: 1. AHI 2. Arousal index 3. Treatment adherence, and 4. Perception of treatment AHI and arousal index will be monitored with overnight PSG and comparisons will be made between the baseline, diagnostic PSG and the two PSGs with TNI (initiation and termination). TNI adherence will be monitored objectively by equipping the TNI device with an objective monitor of use time. This will be accomplished using a small infra-red sensor that will be mounted to the cannula and worn by the patient when TNI is operating. The signal will be sent to a Palm Pilot where the objective compliance data will be recorded and downloaded. Adherence is a complicated variable and, if not normally distributed, may be categorised based upon accepted definitions. In such a case, these categories would be employed as dependent measures of this outcome variable (e.g., percentage patients averaging four hours/night and six hours/night). All participants will be informed that adherence will be monitored to reduce deception. Adherence will be compared to historical controls with PAP therapy. Comfort ratings will be obtained along with patient preference during the course of the study, including with PAP on those participants agreeing to be followed with traditional treatment. Comfort ratings will also be correlated with adherence as a validation of the comfort scale. We will also incorporate measures of self-efficacy for OSA treatment. Self-efficacy has been a strong predictor of long-term adherence and will provide insight into one potential mediator of adherence across conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United States of America
Outcome results
None listed