NCT00665977 (Thermosmart) is a Phase 3 clinical trial of Thermosmart & placebo in Obstructive Sleep Apnea, sponsored by Clayton Sleep Insititute.

Who is sponsoring NCT00665977?

NCT00665977 is sponsored by Clayton Sleep Insititute.

What drugs are being tested in NCT00665977?

Interventions in NCT00665977: Thermosmart & placebo, Placebo Device & Nasacort, Placebo Arm.

What condition does NCT00665977 study?

NCT00665977 studies Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion.

Is NCT00665977 still recruiting?

NCT00665977 is currently completed. Last updated 6 July 2010.

Last reviewed 2010-07-06 · How we verify

NCT00665977: Thermosmart

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure

Completed Phase 3 Last updated 6 July 2010

What this trial tests

Phase 3 trial testing Thermosmart & placebo in Obstructive Sleep Apnea in 44 participants. Completed in 1 July 2010.

Timeline

1 September 2007

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	Clayton Sleep Insititute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	1 September 2007
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	1 location across United States

Drugs / interventions tested

Thermosmart & placebo — full drug profile →
Placebo Device & Nasacort — full drug profile →
Placebo Arm

Conditions studied

Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Nasal Congestion — all drugs for Nasal Congestion →
Sinus Congestion — all drugs for Sinus Congestion →

Sponsor

Clayton Sleep Insititute — full company profile →

Who can join

Adults 16 to 65, any sex, with Obstructive Sleep Apnea or Nasal Congestion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Although an exact & universal definition of CPAP compliance has not been determined. Compliance will be tracked by the CPAP unit and downloaded into an analysis program for review at each visit.
Time frame: 8 weeks

Sponsor's own description

1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™ phase versus the nasal steroid phase. 3. Improvement in nasal symptoms in using CPAP will be significantly improved in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase, and comparable between the heated humidity with Thermosmart™ phase versus the nasal steroid phase. 4. Secondary to improvements in CPAP compliance, measures of daytime functioning and quality of life will improve in the heated humidity with Thermosmart™ versus double placebo.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00665977 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clayton Sleep Insititute
Last refreshed: 6 July 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00665977.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing