Efficacy of the Power Sleep Oral Device in the Management of Snoring and Sleep Apnoea

Phase 1

• Conditions: Sleep apnoea; Snoring; Respiratory - Sleep apnoea

• Registration Number: ACTRN12614001273673
• Lead Sponsor: Associate Professor Jack Gerschman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Apnea Hypopnea Index-Total (AHI-total) score of five (5) or greater (assessed by overnight PSG home sleep study). This includes participants ranging from mild to severe in severity of sleep apnoea.

Exclusion Criteria

Unstable cardiovascular disease (untreated hypertension acceptable);
Upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy;
Dental pathology such as infection, abscess in bone, tumour, cracked teeth, and severe dental decay;
Inability to tolerate oral device due to oral or psychological condition;
Pregnant/Breast Feeding;
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non-compliance to medical regimens, or unwillingness to comply with study requirements;
Known widespread allergy or hypersensitivity (Atopia).

Study & Design

• Study Type: Interventional
• Study Design: Not specified