Treating Comorbid Insomnia with Obstructive sleep Apnoea (COMISA) Study: A new treatment strategy for patients with combined insomnia and sleep apnoea.

Conditions

None listed

Brief summary

1. To conduct a randomized controlled trial of Cognitive Behaviour Therapy for insomnia (CBTi) in patients with co-morbid Obstructive sleep Apnoea (OSA) and insomnia to establish whether CBTi therapy improves Continuous Positive Airway Pressure (CPAP) adherence and sleep-related patient outcomes. 2. To explore whether insomnia and OSA are causally inter-related.

D Bensen-Boakes, A Osman, Leon Lack, Peter Catcheside, Nick A. Antic et al. (12 authors)

Applied Sciences2022-02-097 citations

10.3390/app12041787

Effect of depression, anxiety, and stress symptoms on response to cognitive behavioral therapy for insomnia in patients with comorbid insomnia and sleep apnea: a randomized controlled trial.

Sweetman A, Lack L, McEvoy RD, Catcheside PG, Antic NA, Chai-Coetzer CL, Douglas J, O'Grady A, Dunn N, Robinson J, Paul D, Smith S.

2021-03-0120 citations

10.5664/jcsm.8944

The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial

Alexander Sweetman, R. Doug McEvoy, Simon S. Smith, Peter Catcheside, Nick A. Antic et al. (13 authors)

SLEEP2020-01-1257 citations

10.1093/sleep/zsaa002

Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial

Alexander Sweetman, Leon Lack, Peter Catcheside, Nick A. Antic, Simon S. Smith et al. (13 authors)

SLEEP2019-08-12132 citations

10.1093/sleep/zsz178

Interventions

The intervention is Cognitive Behaviour Therapy for Insomnia (CBTi) plus Treatment As Usual (TAU) for Obstructive Sleep Apnoea. Four 1 hour CBTi sessions will occur at weekly intervals in a face-to-face group session of 2 or more participants (depending on recruitment numbers) before starting on Continuous Positive Airway Pressure (CPAP) therapy at home for 6 months. CBTi Session 1: Sleep education - Bedtime Restriction therapy. CBTi Session 2: Misperceptions of sleep - Polysomnograph (PSG) Fe

The intervention is Cognitive Behaviour Therapy for Insomnia (CBTi) plus Treatment As Usual (TAU) for Obstructive Sleep Apnoea. Four 1 hour CBTi sessions will occur at weekly intervals in a face-to-face group session of 2 or more participants (depending on recruitment numbers) before starting on Continuous Positive Airway Pressure (CPAP) therapy at home for 6 months. CBTi Session 1: Sleep education - Bedtime Restriction therapy. CBTi Session 2: Misperceptions of sleep - Polysomnograph (PSG) Feedback. CBTi Session 3: Hyperarousal and Anxiety in Insomnia. CBTi Session 4: Review and Relapse Prevention. Participants will be asked to keep four 1-week sleep diaries and a record of their thoughts and feelings on sleep. Participants receiving CBTi will given a CBTi Participant Manual which explains the process of sleep and some of the factors which can cause and maintain insomnia and effective treatment and strategies for insomnia.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. Age greater than or equal to18 years of age up to and including 75 years of age. 2. An apnoea/hypopnoea index (AHI) greater than 15 events per hour of sleep by polysomnography (PSG) with clinical diagnosis of OSA confirmed by treating consultant respiratory physician. 3. Recommended by treating sleep physician for CPAP treatment. 4. A diagnosis of Insomnia to ICSD-2 criteria, Insomnia Severity Index Score greater than 13.

Exclusion criteria

1. Severe daytime sleepiness, or other reason, which in the opinion of the treating physician would cause undue risk to the patient’s safety during the CBTi treatment period while awaiting CPAP treatment. 2. Any other sleep disorder (eg REM behaviour disorder, severe restless legs syndrome) which in the opinion of the treating physician is the dominant sleep diagnosis and which requires immediate treatment. Patients with other medical or psychiatric conditions (e.g. depression & anxiety) will not be excluded, but diagnoses recorded from the patient’s file for reporting and analysis purposes.

Outcome results